Exam Code: EPPP Practice exam 2023 by Killexams.com team
EPPP Examination for Professional Practice of Psychology

The Examination for Professional Practice in Psychology (EPPP) is developed and owned by the Association of State and Provincial Psychology Boards (ASPPB). The EPPP is provided to state and provincial boards of psychology to assist them in their evaluation of the qualifications of applicants for licensure and certification. This standardized knowledge-based examination is constructed by ASPPB with the assistance of its test vendor, Pearson VUE. The EPPP is continuously administered in a computerized delivery format through the Pearson VUE network of computer testing centers. State and provincial psychology boards acting collectively through ASPPB provide support for the testing format. Pearson VUE maintains a network of more than 275 Pearson Professional Centers (PPCs) in the United States and Canada in order to provide access to computer-based testing (CBT) for candidates.
The resources of individual psychologists, ASPPB and its test vendor are used in the ongoing development of and improvements to the EPPP. These combined resources are greater than those available to any individual psychology licensing. The EPPP is only one part of the evaluation procedures used by state and provincial boards to determine candidates readiness to practice the profession of psychology. Most boards supplement the EPPP with other requirements and/or assessment procedures. The EPPP is intended to evaluate the knowledge that the most accurate practice analysis has determined as foundational to the competent practice of psychology. Most candidates taking the EPPP have obtained a doctoral degree in psychology, a year of predoctoral supervised experience and appropriate postdoctoral experience. Candidates are expected to have acquired a broad basic knowledge of psychology, regardless of individual areas of concentration. This knowledge, and the candidates ability to apply it, are assessed through the candidates responses to objective, multiple-choice questions that are representative of the field at large. The average pass-rate for doctoral level candidates who are taking the exam for the first time exceeds 80% in the most accurate trial years.

Regardless of the jurisdiction, in order to sit for the EPPP, individuals seeking licensure must first apply for licensure to the licensing authority in the state, province or territory in which they wish to be licensed. The licensing authority reviews applicants credentials and determines if they meet the requirements established in the laws of the state, province or territory.

Candidates who meet their licensing authorities requirements will be pre-approved by the board to take the EPPP. The board will enter the candidates identifying information into an online EPPP registration system that will enable the candidate to logon and verify her/his account, and that gives access to the application materials. Candidates will be sent two consecutive emails, the 1st advising them that their licensing authority has uploaded their information into the system, and the 2nd with information for them to verify their account and begin the registration process.  Candidates will not be able to log into the registration system until their licensing authority has uploaded their information. Candidates must contact their board to advise that they are ready to test and need to be uploaded to the EPPP registration system.

Candidates may test at any authorized Pearson VUE center that administers the EPPP, regardless of the jurisdiction where they are applying for licensure. Candidates must arrive 30 minutes prior to their scheduled appointment. Please Note: Candidates must have a currently valid, government-issued photo ID (e.g., passport, drivers license, etc.), as well as another piece of identification imprinted with their name and containing a signature or accurate photo (e.g., credit card, CPR card, etc.). The first and last name on both forms of ID must match the name on the Authorization to Test email.

Prior to taking the EPPP, candidates will be asked to read and acknowledge their review of the Candidate Acknowledgment Statement. Please note that the Candidate Acknowledgement Statement contains important rules for taking the EPPP and should be read in its entirety before acknowledging that it has been read.
The EPPP is administered under standardized conditions in accordance with procedures established by Pearson VUE for all their testing centers. • Candidates taking the EPPP are allowed: o 5 minutes to agree to the terms of the Candidate Acknowledgement Statement (If you do not agree to the terms within the 5- minute timeframe, the exam will be canceled and cannot be reset), o 5 minutes for completion of the tutorial, o 4 hours and 15 minutes for completion of the EPPP and 5 minutes at the end of the exam allotted to complete a brief survey. • Candidates with documented disabilities or impairments, who wish to be tested under nonstandard conditions, please see the section regarding “Special Accommodations” on page 7. There are no scheduled breaks during the Exam. Candidates may take breaks whenever they wish; however, the clock on the time allotted for the Exam will continue to run.

Pearson Professional Centers are built to standard specifications and vary primarily on the basis of size. Private modular workstations provide ample workspace, comfortable seating, and proper lighting. Proctors monitor the testing process through an observation window and from within the testing room. Parabolic mirrors mounted on the walls assist proctors in observing the testing process. All testing sessions are videotaped and audio-monitored, and a digitized image of all candidates taking the EPPP will be retained. Computer knowledge is not required to take a computerized examination. Before the examination begins, a basic introductory lesson (tutorial) is presented that explains the process of selecting answers and moving from question to question. Candidates have 5 minutes to complete the tutorial, and are strongly encouraged to review it carefully.

Candidates may select their answers using either the keyboard or the mouse. During the tutorial, candidates will learn how they can skip forward or backward through the EPPP to review questions. Candidates should be sure they understand how to review questions when they take the tutorial. The testing software contains a feature that allows candidates to flag questions they might wish to review later, if time permits. Any question can be flagged, regardless of whether it has been left blank or answered, and will be scored even if it is still marked upon completion of the Exam.
Candidates are encouraged to take notes during the tutorial on whiteboards that can be supplied by the testing center upon request. They are not automatically supplied. Testing center staff will collect whiteboards at the completion of the Examination. Candidates are not allowed to bring their own scratch paper or writing instruments into the testing room. Please Note: There might be some distractions in the testing situation because: • Other candidates may be taking exams that require narrative responses, and there may be keyboard noise.
• Proctors will be entering the testing room on a regular basis to observe activity and to seat other candidates or answer inquiries. • Other minor distractions might include ambient noise from outside the testing room. If a candidate is concerned that these kinds of distractions will affect exam performance, he or she may request earplugs and/or noise cancelling headphones after arriving at the testing center. This does not require pre-approval. Candidates are not allowed to bring their own earplugs into the testing room.
The total number of correct responses determines a candidates score. Therefore, it is to the candidates advantage to answer every item, even when uncertain of the correct response. The candidate should choose the single best answer to each item.

Examination for Professional Practice of Psychology
Medical Professional basics
Killexams : Medical Professional basics - BingNews https://killexams.com/pass4sure/exam-detail/EPPP Search results Killexams : Medical Professional basics - BingNews https://killexams.com/pass4sure/exam-detail/EPPP https://killexams.com/exam_list/Medical Killexams : Learn the Basics of Medical Device Packaging

There is a lot to learn if you are making a career transition into or entering the medical packaging field.

Thankfully, the Medical Device Packaging Technical Committee (MDPTC) of the Institute of Packaging Professionals is here to help. This committee invested in developing Fundamentals of Medical Device Packaging to enable rapid learning about medical device packaging.

The course was first offered at Pack Expo International 2022 and featured classroom and expo floor instruction.

If you are considering the course, listen in as five medical device packaging leaders debriefed the merits of this course in a SPOT Radio podcast, by Charlie Webb, Founder and President of Van der Stahl Scientific and CPPL (“lifetime” Certified Packaging Professional).SPOT stands for Sterile Packaging on Track.

The five leaders interviewed are myself, Dannette Casper, Package Engineer, Edward LifeSciences; Sarah Rosenblum, Senior Director of Sales & Marketing, and Cassandra Ladd, Senior Marketing Manager, both at Packaging Compliance Labs; Art Castronovo, Director Package Engineering and Product Labeling at Johnson and Johnson; and Jennifer Benolken, MDM & Regulatory Specialist, Packaging Engineering, DuPont Tyvek, Healthcare Packaging.

Highlights of their conversation include:

1. Synopsis of the new Medical Device Packaging Fundamental’s class, which covers all the steps/functions of packaging a medical device, from design to launch.

2. Review of the premier offering at Pack Expo. It was sold out! And attendees were highly engaged. Their peer-to-peer participation added to the richness of the content presented by the experts.

3. Expectations for the second Medical Device Packaging Fundamental’s class at MD&M West in Anaheim, Calif., The show runs from February 7-9, but the Fundamental’s class starts on the afternoon of February 6 and runs until February 8.

Registration is now open for this second class and you can sign up here. MD&M West is co-located with WestPack.

Wed, 15 Feb 2023 09:59:00 -0600 en text/html https://www.plasticstoday.com/medical/learn-basics-medical-device-packaging
Killexams : The basics of cardiac arrest

On a Monday night in early January 2023, the Buffalo Bills were in Cincinnati to take on the hometown Bengals. The game was a highly anticipated, primetime matchup between two of the best teams in the National Football League, but it would be interrupted and ultimately postponed after Bills safety Damar Hamlin suffered a frightening injury during the game. After tackling Bengals wide receiver Tee Higgins, Hamlin stood up, only to fall flat moments later. Medical personnel rushed to Hamlin's side, and it was later determined he went into cardiac arrest.

Days went by as football fans across the nation prayed for Hamlin's recovery. Good news arrived by the end of the week, as doctors treating Hamlin reported his condition showed marked improvement. Indeed, within days of that news, Hamlin was on his way back to Buffalo, much to the delight of millions of people across the country.

Hamlin's story made international headlines and left many people across the globe asking questions about cardiac arrest.

What is cardiac arrest?

The National Heart, Lung, and Blood Institute reports that cardiac arrest occurs when the heart suddenly and unexpectedly stops pumping. One of the dangers of cardiac arrest is that blood stops pumping to the brain and other vital organs. In the days after doctors first shared news regarding Hamlin's recovery, praise was heaped on the medical personnel, including Bills assistant athletic trainer Denny Kellington, for their rapid response, which saved Hamlin's life and helped preserve the 24-year-old safety's neurological function.

How dangerous is cardiac arrest?

The NHLBI notes that cardiac arrest is a medical emergency. In fact, the NHLBI indicates that nine out of 10 people who have cardiac arrest outside of a hospital die. That makes the recovery of Hamlin, who was administered CPR on the field for several minutes prior to being transported to the hospital, all the more incredible.

What are the symptoms of cardiac arrest?

Johns Hopkins Medicine notes that there are no symptoms in some cases of cardiac arrest. However, individuals may experience these symptoms prior to cardiac arrest:

· Fatigue

· Dizziness

· Shortness of breath

· Nausea

· Chest pain

· Heart palpitations

· Loss of consciousness

What causes cardiac arrest?

The suddenness of the injury to Hamlin undoubtedly left millions of people confused about how the condition could affect a young professional athlete seemingly in peak physical condition. Specifics about Hamlin's medical history are protected by privacy laws, so unless Hamlin chooses to share that information, the public will not learn about why he suffered from cardiac arrest. However, Johns Hopkins reports that there are three main causes of the condition.

· Arrhythmia and ventricular fibrillation: Arrhythmia is a condition marked by problematic electrical signals in the heart that lead to an abnormal heartbeat. Ventricular fibrillation is a type of arrhythmia that causes the heart to tremble rather than pump blood normally. It is the most common cause of cardiac arrest.

· Cardiomyopathy: Cardiomyopathy is a condition in which the heart is enlarged. Johns Hopkins notes that when a person has cardiomyopathy, the heart muscle thickens or dilates, which causes abnormal contractions of the heart.

· Coronary artery disease: The NHLBI indicates that most people who experience cardiac arrest have heart disease, even if they didn't know it beforehand. The most common type of heart disease is coronary artery disease, which is marked by the buildup of cholesterol inside the lining of the coronary arteries. That buildup leads to the formation of plaque which can partially or completely block blood flow in the arteries of the heart.

Certain behaviors or lifestyle choices also can trigger cardiac arrest. For example, the NHLBI reports that heavy alcohol consumption or accurate use of cocaine, amphetamines or marijuana can cause cardiac arrest. Severe emotional stress and physical exertion, including that which is typically required of competitive athletes, also can trigger cardiac arrest.

The Damar Hamlin incident thankfully appears to have had a happy ending. But millions more people could be vulnerable to cardiac arrest. More information is available at nhlbi.nih.gov.

Sun, 19 Feb 2023 03:05:00 -0600 en text/html https://www.postandcourier.com/kingstree/community-news/the-basics-of-cardiac-arrest/article_b872c9a2-aeed-11ed-94de-636a8c2e05cc.html
Killexams : Medical Imaging: The Basics of FDA Regulation


Image courtesy of SIEMENS (Malvern, PA)

Medical imaging is playing a large and increasing role in modern healthcare delivery. Physicians and other healthcare professionals routinely rely on the diagnostic information provided by advanced imaging techniques such as ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI) in their clinical practices. Surgeons, interventional cardiologists, and interventional radiologists employ a variety of state-of-the-art techniques to guide percutaneous treatments and interventions. Understanding FDA's regulatory construct that governs medical imaging is crucial to manufacturers operating in this exciting and challenging environment.

Regulation of Existing Imaging Technologies

Devices used in medical imaging are considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Medical Device Amendments of 1976 and subsequent related amendments.1,2 Most existing medical imaging technologies are considered non-510(k)-exempt Class I and Class II medical devices by FDA, making them eligible for clearance under the 510(k) pathway.

Under this pathway, new medical devices that are substantially equivalent to existing, legally marketed Class I and Class II devices in terms of intended use, indications for use, and technological characteristics may be cleared for the U.S. market. The legally marketed devices with which comparison is made are referred to as predicate devices.

Under the 510(k) pathway, a next-generation imaging technology may be found substantially equivalent. However, the intended use and indications for use of the device must remain essentially unaltered. Intended use generally refers to the overall purpose of a device. The indications for use define the particular conditions or locations to which the device is to be applied. Also, any technological differences in comparison to the predicate device must not raise new questions of safety or effectiveness. However, if a new intended use or indication for use is sought, or if the technology employed raises new questions of safety or effectiveness when compared with the predicate, the new device is designated as Class III and requires a premarket approval (PMA) application. The PMA process requires a demonstration of safety and effectiveness prior to the granting of marketing approval.

Advanced imaging techniques, such as those used in the Gemini GXL from Philips (Andover, MA), are changing healthcare delivery.

Existing imaging devices use a variety of technologies to obtain diagnostic information or guide therapeutic procedures. These devices may be broken down into modalities that use and those that do not use ionizing radiation to form medical images.

Imaging Devices Using Ionizing Radiation. X-rays are the oldest form of medical imaging. They generate images, known as radiographs, by using ionizing radiation. The majority of the equipment used to produce, control, and process x-rays to generate radiographs is Class I or Class II. actual classification (depending on the type of device) ranges from Class I 510(k)-exempt products such as diagnostic x-ray tube housings, which produce the x-ray beam, to Class II non-510(k)-exempt solid-state x-ray imagers or digital flat panels.

X-ray devices are representative of the product evolution that is possible in the 510(k) pathway. Such devices have become progressively more sophisticated, moving from purely analog imaging methods (i.e., the x-rays pass through the body part being imaged and directly onto a film, which is then processed for interpretation) to modern digital methods (i.e., the x-ray strikes a detector system, which then converts the received x-rays into an image). This evolutionary change was made possible by successive technological improvements in predicate devices over time, all generally cleared via the 510(k) pathway.

A notable exception is digital mammography, for which FDA has required PMA approval. The original designation of digital mammography as Class III is attributed to both its indications for use (detection of breast cancer) and the application of new technology to that indication. Currently, there is serious consideration being given to downclassifying it to Class II.

Fluoroscopy, which is closely related to x-ray imaging, allows both static and dynamic x-ray imaging. Like x-ray, fluoroscopy is a long-established imaging process that has undergone considerable technological advances since 1976, all essentially within the 510(k) pathway. Modern digital fluoroscopic equipment, which allows for image processing and manipulation, would have been technically impossible in 1976. Yet it is now considered Class II and subject to a variety of special controls.

CT scanners existed prior to 1976 and were placed into Class II by the original medical device classification panels. As for x-ray and fluoroscopic technology, the 510(k) path allowed CT technology to progress from fairly simple single x-ray source-and-detector configurations to the sophisticated spiral and multidetector technologies available today. FDA regulations describing what constitutes a CT scanner for regulatory purposes are fairly typical of the general nature of such regulations in medical imaging. A CT scanner is defined as

[A] diagnostic x-ray system intended to produce cross-sectional imaging of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis component parts and accessories.3

The FD&C Act is not the only FDA regulation applicable to x-ray, fluoroscopy, CT scanners, and other medical imaging devices that emit ionizing radiation and certain other types of energy. The Radiation Control for Health and Safety Act of 1968 (subsequently incorporated into the FD&C Act at Sections 531–542) addresses such devices. It authorizes FDA to promulgate performance standards for these radiation- and energy-emitting products to minimize unnecessary emission and exposure.4 This legislation applies to any ionizing or nonionizing electromagnetic or particulate radiation; or sonic, infrasonic, or ultrasonic waves emitted from an electronic product as a result of an electronic circuit. Accordingly, any imaging device that emits ionizing radiation marketed in the United States must meet FDA performance standards as well as gain 510(k) clearance.5 The content of the often-complex reports required to satisfy these requirements may be found in various sections of 21 CFR Parts 1000–1050.

Imaging Devices Not Employing Ionizing Radiation. A growing number of medical imaging products do not rely on ionizing radiation to produce images. Diagnostic ultrasound technologies also existed before 1976. Regulated as a Class II device, diagnostic ultrasound has incorporated a number of substantial technological advances since 1976. The result is a variety of features (i.e., color Doppler vascular imaging and 3-D imaging) that vastly Excellerate its diagnostic capabilities. Like advances in x-ray, fluoroscopy, and CT scanning, diagnostic ultrasound's considerable evolutionary progress has been possible within the 510(k) process. Notably, its Class II designation includes a variety of imaging transducers for both external and internal use, including intravascular ultrasound catheters used for imaging coronary arteries. In addition to the FD&C Act requirements, ultrasound equipment is also subject to FDA performance standards developed under the Radiation Control for Health and Safety Act, given the emission of ultrasonic waves from these devices.

MRI uses powerful magnetic fields in conjunction with radio-frequency pulses and sophisticated computer algorithms to produce detailed anatomic and functional images. Unlike the previous modalities, clinically usable MRI technology was not developed until the early 1980s and consequently had no predicate device when first brought to market. Because the risk to patients undergoing the then-new procedure was not well characterized, MRI was initially regulated as a Class III device and entered the market through the PMA process. Following the widespread clinical introduction of MRI, considerable clinical data were collected demonstrating the relative safety of the technique. Based on this well-defined risk profile, FDA reclassified MRI, MR spectroscopy, and related coils as Class II devices effective July 28, 1988, allowing them to gain marketing approval via the 510(k) pathway.

Related Imaging Management Equipment. In modern clinical practice, medical imaging devices are only part of the medical imaging enterprise. Images obtained by these devices must be captured, stored, and distributed for both primary interpretation and clinical review. This typically requires a picture archiving and communications system (PACS) together with a variety of related components.

PACS devices and their related components depend on computer workstation technology that was not available in 1976. There also was confusion among manufacturers as to whether these products were medical devices, and if so, how they were to be regulated. Culminating in a final rule issued on April 29, 1998, FDA clarified its treatment of PACS and related devices.6 Under these regulations, medical image storage devices and medical image communications devices are Class I exempt if they do not use irreversible compression. PACS devices, along with medical image digitizers (e.g., film scanners) and medical image hard-copy devices (e.g., film printers), are considered Class II and subject to 510(k) premarket notification. Accordingly, PACS devices, medical image digitizers, and medical imaging hard-copy devices require FDA clearance before they may be legally marketed.

Bringing a New Medical Imaging Device to Market

X-rays are the oldest form of internal medical images.

Given that the majority of medical imaging technology is subject to the 510(k) pathway or is even 510(k) exempt, it might appear that bringing new imaging devices to market is a relatively straightforward process. However, this may not be the case if a new product differs from its potential predicate devices in intended use or indications for use, or if it uses modified or new technology. Even if a new device is considered to present a low risk of patient injury, such changes can have a substantial effect on the product's path to market.

Alterations to an Intended Use or Indications for Use. A new imaging device's intended use is key to determining whether that new product is substantially equivalent to a claimed predicate device.7 If a new device's intended use is determined to be not substantially equivalent (NSE) to a predicate device, the new product is subject to an automatic Class III designation. In practice, the broad intended uses of medical imaging devices generally afford sponsors considerable latitude in identifying an intended use that is reasonably applicable to a new imaging product.

The 510(k) pathway allows sponsors some flexibility with a new device's indications for use. Generally, differences in a new device's indications for use as compared with its predicates' does not preclude a substantially equivalent determination. Of course, those differences must not alter the product's intended diagnostic or therapeutic effect. When examining whether such alterations exist, FDA looks to whether the change affects the device's safety and effectiveness compared with that of its predicates.

In practice, minor alterations in the indications for use for an existing imaging technology are often not viewed by FDA as altering a product's diagnostic or therapeutic effect. An example is limiting the application of a cleared imaging technology to a specific area of the body.

More-pronounced changes to a device's indications for use, such as incorporating disease-specific claims (i.e., cancer detection) where the predicate products made only general imaging claims, may cause difficulties in establishing substantial equivalence. In such instances, FDA could easily see the modified indication as affecting the device's diagnostic effect. A relevant example is FDA's treatment of digital mammography. The addition of a breast cancer–screening claim to a breast-specific refinement of digital imaging technology was a major factor in FDA's classification decision. In that case, FDA did require a PMA, even though similar, existing digital imaging systems without a specific cancer-screening indication had been subject to 510(k) clearance. The decision to require a PMA for digital mammography was difficult for many in the imaging community to accept. Nonmammography digital imaging systems with broad indications for use were routinely used in the diagnosis and management of cancer, despite the lack of an explicit cancer-related indication for use. Simply put, even the most established imaging technology may be subject to the PMA pathway if a new indication significantly alters that technology's established diagnostic effects.

Alterations to Device Technology. Assuming that the intended use of a new device is unchanged from its predicates and the indications for use do not alter its diagnostic or therapeutic effect, the substantial equivalence analysis shifts to the technology used to create the images. Should that technology be substantially similar to that of the new product's predicate devices, substantial equivalence is established.

However, if a new product's technology differs from that of the predicate devices, the question becomes whether the change could significantly affect safety or effectiveness. If the answer is no, as might be the case with a minor alteration to image manipulation capabilities or the algorithm by which those images were generated, the product is considered substantially equivalent. However, if the change in technology might significantly affect safety or effectiveness, the analysis moves to whether that change does in fact raise new questions of safety or effectiveness.

The analysis of whether new technological characteristics raise new concerns of safety or effectiveness is often the key question with innovative imaging products. Such products often use completely new methods to obtain diagnostic information. Even if such technology is unquestionably safe, the novel nature of a new device's technology may raise questions of effectiveness. For example, if the imaging technology does not impart energy of any kind into the patient or uses a type of energy whose risks are well characterized, FDA may question the technology's effectiveness. Whenever a new device's technological characteristics do raise new questions, the agency's substantial equivalence analysis ends with an NSE determination.

Consider instances where FDA accepts that no new questions of safety and effectiveness have been raised by a new imaging device's technology. A sponsor must still demonstrate that accepted scientific methods exist for assessing the new technological characteristics and present performance data obtained using those methods to prove substantial equivalence. In practice, clinical data are frequently necessary to establish that the technology has safety and efficacy comparable to its predicates. Designing and conducting clinical studies to demonstrate comparable safety and effectiveness may be difficult. Typically, it requires demonstration of the new product's clinical utility. This, in turn, generally requires the use of the new device to evaluate a specific clinical condition whose existence can be confirmed with a reasonable degree of confidence. This confirmation allows the sensitivity and specificity of the new imaging product to be compared with its predicate devices in a clinical setting in which the new device is to be used.

Approaches to a Not Substantially Equivalent Determination. Should FDA determine that the intended use of a new imaging device differs from that of its predicates, that its indications for use change its effect, or that it raises new questions of safety or effectiveness, agency policy requires that the new device be found NSE.

There are certain indications from FDA that an NSE determination is likely. These include a letter requesting additional information and containing questions that the sponsor cannot address with data that are either on hand or reasonably available.

There are several strategies for dealing with an NSE decision, depending on the underlying basis for the determination.

One potential reason for an NSE decision could be that the intended use has gone beyond the predicate device's intended use. For example, a particular indication for use, such as a claim that an imaging device can either screen for or characterize certain forms of cancer, may require the submission of extensive clinical data or a PMA prior to receiving marketing approval.8 Abandoning or modifying that particular indication, assuming that there were no agency questions with regard to the device's underlying technology, may allow the product to be cleared via the 510(k) pathway.

Similarly, it is not unusual for FDA to object to particular aspects of a new device's technology, such as a specific pulse sequence or imaging algorithm. Removing the portion of the new product's technology that has raised the agency's concern may often allow a substantial equivalence determination to be made on a modified, although less-capable, version of the device.

In instances where a novel new imaging device is low risk but NSE to a predicate device, de novo downclassification under Section 513(f)(2) of the FD&C Act may be an option. Under this pathway, the new device is downclassified into Class I or Class II and subsequently cleared by the agency. FDA will note that a particular device may be eligible for the de novo pathway in the letter notifying the sponsor of the agency's NSE decision. However, if the de novo pathway is being considered, the downclassification should be discussed well before any 510(k) notice is submitted.

To qualify for de novo downclassification, the new imaging device must meet the statutory requirements for inclusion in either Class I or Class II. Administratively, the sponsor must submit a written request for downclassification within 30 days of receiving an NSE letter. The request should include a description of the device, the rationale for the downclassification, and information to support the request. This submission should also discuss proposed general or special controls for the new product that can provide reasonable assurance of its safety and effectiveness.

In practice, clinical data are often necessary, and the downclassification request is typically prenegotiated with FDA. Submission of that request is usually made immediately following the agency's pro forma issuance of an NSE determination. These considerations notwithstanding, FDA has 60 days following the submission of the written request to downclassify the new device. If the agency finds that the product is properly classified in Class I or Class II, the device may be commercially distributed based on the information submitted as part of the de novo downclassification request. However, if FDA finds that the new device is appropriately in Class III, the new device is subject to the PMA process. Although attractive in concept, the de novo process is still used infrequently.

In instances where FDA will not consider either the 510(k) or de novo pathways for a medical imaging device, the PMA pathway is the only option to bring a new imaging device to market. Under the PMA paradigm, clinical trials are necessary to demonstrate that the device is reasonably safe and effective for its intended use and indications for use. As noted earlier, designing clinical studies for imaging products can be challenging, particularly demonstrating a new device's effectiveness and clinical utility. Depending on the particulars of the technology, these studies may have to demonstrate not only that the device can successfully detect a disease or condition with a certain sensitivity and specificity, but also that physicians and other healthcare professionals can use the information provided in a clinically useful manner. Even in instances where the clinical trials for a PMA are comparable in size and complexity with those needed for a 510(k) notice or de novo downclassification, sponsors of a PMA-pathway device are typically subject to substantially higher user fees and a preapproval manufacturing inspection.


FDA regulation of medical imaging devices may appear to some as deceptively simple, because the majority of imaging products are subject to the 510(k) pathway. However, when a sponsor is contemplating new or modified indications for use for an established imaging technology, a variation of established technology, or a totally new technology, the sponsor should fully and realistically explore the potential regulatory consequences.

When developing a substantial equivalence argument for such a product, it is often prudent to consider alternatives to the planned device in terms of intended use and technology, in case FDA initially rejects the claim of substantial equivalence. In considering these options, sponsors should also perform a realistic assessment of the resources available to design and develop clinical trials should clinical data be necessary for 510(k) clearance or should de novo downclassification or a PMA prove necessary.

John J. Smith is counsel at Hogan & Hartson LLP (Washington, DC) where he specializes in regulatory and scientific issues related to FDA marketing approval for medical devices. Smith can be contacted at [email protected].


1. Federal Food, Drug, and Cosmetic Act, Public Law 75-717, 52 Stat. 1040 (1938), 21 USC Sections 301–394.

2. Medical Device Amendments of 1976, Public Law 94-295, 90 Stat. 539 (1976; codified as amended in scattered sections of 21 USC).

3. Code of Federal Regulations, 21 CFR 892.1750.

4. Radiation Control for Health and Safety Act of 1968, Public Law 90-602, 82 Stat. 1171 (1968).

5. Code of Federal Regulations, 21 CFR 1040.

6. Federal Register, 63 FR:23385, April 29, 1998.

7. “Guidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3),” Blue Book Memorandum (Rockville, MD: FDA, CDRH, 1986).

8. “Guidance for Industry: General/Specific Intended Use” (Rockville, MD: FDA, CDRH, 1998).

Copyright ©2006 Medical Device & Diagnostic Industry

Tue, 14 Feb 2023 10:00:00 -0600 en text/html https://www.mddionline.com/radiological/medical-imaging-basics-fda-regulation
Killexams : Unlicensed medical professionals, citizens must stay alert He examined patients and performed some limited surgeries. He is a doctor who initially specialized in urology. Still, he practiced the profession generally and examined various cases broader than his specialization.

In his home or clinic, which was raided by the State Security Agency, accompanied by a doctor of the Ministry of Health in Bekaa, about two weeks ago, the agency found smuggled medicines, surgical instruments, and other equipment.

 Inspection of the place indicates the absence of the most basic standards of hygiene and sterilization and the lack of technical, medical, and health conditions necessary for patient safety.

The non-fulfillment of these conditions is the practical danger of such a doctor to Lebanese, Syrian, and other patients. He is a doctor working in violation of the law without a license.

Another case was recently reported in the Bekaa Valley.

With the suffocating crisis and the increase in the number of displaced Syrians, charitable clinics resort to hiring Syrian doctors who enter secretly and illegally.

In a charitable center in Qab Elias, the director is Lebanese. Yet, State security officers have arrested two Syrian doctors who work illegally.

The Public Prosecution Office in the Bekaa released them after signing a pledge not to practice the medical profession until after obtaining licenses. The center’s director also signed a pledge stating that he would not hire non-Lebanese doctors in a way that violates the laws.

Sat, 11 Feb 2023 04:00:00 -0600 en text/html https://www.lbcgroup.tv/news/news-bulletin-reports/686939/unlicensed-medical-professionals-citizens-must-sta/en
Killexams : ChatGPT takes on the tough US medical licensing exam

Dr. ChatGPT will see you soon. The artificial intelligence system scored passing or near passing results on the US medical licensing exam, according to a study published on Thursday.

"Reaching the passing score for this notoriously difficult expert , and doing so without any human reinforcement, marks a notable milestone in clinical AI maturation," said the authors of the study published in the journal PLOS Digital Health.

"These results suggest that large language models may have the potential to assist with medical education, and potentially, clinical decision-making," they said.

ChatGPT, which is able to produce essays, poems and programming code within seconds, was developed by OpenAI, a California-based startup founded in 2015 with early funding from Elon Musk among others.

Microsoft invested $1 billion in OpenAI in 2019 and just inked a new multi-billion deal with the firm.

For the study, researchers at California-based AnsibleHealth tested ChatGPT's performance on a three-part licensing exam taken by and physicians-in-training in the United States.

The standardized exam tests knowledge in multiple medical disciplines from basic science to biochemistry to diagnostic reasoning to bioethics.

The AI system was tested on 350 of the 376 public questions on the June 2022 version of the exam, the study said, and the chatbot was not given any specialized training ahead of time.

Image-based questions were removed.

ChatGPT scored between 52.4 percent and 75 percent across the three parts of the exam.

A passing grade is around 60 percent.

According to the study, the first part of the exam, which focuses on and pharmacology, is typically taken by medical students who have put in 300-400 hours of dedicated study time.

The second part is generally taken by fourth-year medical students and emphasizes clinical reasoning, and bioethics.

The final section is for physicians who have completed at least six months to a year of postgraduate .

The questions were presented to ChatGPT in various formats including open-ended prompting such as "What would be the patient's diagnosis based on the information provided?"

There were also multiple choice questions such as: "The patient's condition is mostly caused by which of the following pathogens?"

Two physician adjudicators who were blinded to each other reviewed the responses to come up with the final grades, the study said.

An outside expert, Simon McCallum, a senior lecturer in at Victoria University of Wellington, New Zealand, noted that Google has received encouraging results with an AI medical tool known as Med-PaLM.

"ChatGPT may pass the exam, but Med-PaLM is able to deliver advice to patients that is as good as a professional GP," McCallum said. "And both of these systems are improving.

"Society is about to change, and instead of warning about the hypochondria of randomly searching the internet for symptoms, we may soon get our from Doctor Google or Nurse Bing."

ChatGPT also proved useful to the authors of the medical exam study in another way.

They used the chatbot to help write it, said co-author Tiffany Kung.

More information: Performance of ChatGPT on USMLE: Potential for AI-assisted medical education using large language models, PLOS Digital Health (2023). DOI: 10.1371/journal.pdig.0000198

© 2023 AFP

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Thu, 09 Feb 2023 07:17:00 -0600 en text/html https://techxplore.com/news/2023-02-chatgpt-tough-medical-exam.html
Killexams : Basic facilities for medical teams at check posts across TN soon: Health Minister

By Express News Service

COIMBATORE:  Minister for Health and Family Welfare Ma Subramanian on Friday said basic infrastructure for medical teams will be established at the check posts along the State border.

The minister announced the plan to mediapersons after chairing a meeting with health officials, medical experts and voluntary organisations regarding the projects to be included in the health and family welfare department in the upcoming financial year.

“State planning committee members, health department officials, medical experts, voluntary organisations and activists expressed their views. “This is the first and the foremost initiative to hold a consultation on programmes to be implemented in the field of health and family welfare. The views expressed in the meeting will be taken to the attention of the chief minister and action will be taken to include them in the budget,” the minister said. 

Further, he pointed out that 24 government hospitals were upgraded to district head hospitals and that 50 primary health centres (PHC) were established last year.  “During the outbreak of infectious diseases like Covid-19 and tomato fever, check posts were set up by the respective district health department in the border to screen people coming from other states.

Necessary infrastructure will be established for medical teams working at check posts. The government is also considering action under the Goondas Act against those dumping medical waste in waterbodies, public places,” the minister also said.

Fri, 17 Feb 2023 14:32:00 -0600 text/html https://www.newindianexpress.com/states/tamil-nadu/2023/feb/18/basic-facilities-for-medical-teams-at-check-posts-across-tn-soon-health-minister-2548522.html
Killexams : Bill of firemen certification as medical responders OK’d

With an overwhelming 236 votes, the House of Representatives on Wednesday approved on third and final studying a bill requiring Bureau of Fire Protection (BFP) personnel to be certified medical first responders and emergency medical technicians.

House Speaker Martin G. Romualdez said the requirement under House Bill (HB) 6512 “will save lives.”

“In emergency situations like a fire, an earthquake or a road accident, BFP personnel are often, if not always, the first responders. They have to have adequate basic medical training to assist and save victims,” Speaker Romualdez said.

“This is the reason why fire departments in many countries, including our own BFP, are mandated to have emergency medical service (EMS) units,” he said.

Romualdez added that the type and quality of training EMS personnel receive “can spell life or death for persons needing immediate medical assistance.”

He cited the accurate case of a popular American football player who collapsed after tackling an opponent during a nationally televised game.

The player suffered cardiac arrest and his heart stopped beating. First responders administered cardiopulmonary resuscitation (CPR) on him for 10 minutes before he was taken to a hospital. Many American doctors said the CPR given by responding personnel saved the player’s life.

They have also predicted that he could soon return to professional football.

“Ideally, that is the emergency response we want to achieve with the required certification and training for our BPF-EMS personnel under House Bill No. 6512,” Speaker Romualdez said.

The proposed law would amend Section 4 of Republic Act (RA) No. 11589, otherwise known as the Bureau of Fire Protection (BFP) Modernization Act. It is principally authored by Antipolo City Rep. Romeo Acop.

It would require the BFP regional director to designate in every fire station at least one uniformed employee, regardless of rank, to act as an emergency medical technician who will supervise fire officers in responding to medical emergencies.

The bill defines an emergency medical technician as “a trained and certified pre-hospital emergency care provider who is capable of performing extensive pre-hospital care, endotracheal intubations and cardiopulmonary resuscitation; administering medications orally and intravenously; and using automated external defibrillator and other complex emergency medical equipment.”

Wed, 15 Feb 2023 00:20:00 -0600 en-US text/html https://www.manilastandard.net/news/314305727/bill-of-firemen-certification-as-medical-responders-okd.html
Killexams : Union Budget 2023 has put a lot of emphasis on R&D and basic medical education: Shanay Shah
Union Budget 2023 has put a lot of emphasis on R&D and basic medical education: Shanay Shah
by Shanay Shah

“The Union Budget 2023 is centred on a comprehensive plan to accelerate economic growth. Having established a solid foundation for a robust healthcare ecosystem over the past few years, this year's budget has put a lot of emphasis on R&D and basic medical education. It was revealed that 157 new nursing institutions would be set up alongside the existing 157 medical colleges. This is a much-needed move that will aid in preparing the nation for adequately trained healthcare workforce which will also help our country to strength its position in all the global healthcare parameters. This action will also assist in filling the huge demand of healthcare professionals, particularly in tier 2 and tier 3 cities. The government also initiated a multidisciplinary medical device course for skilled workers that will create a competent workforce to Excellerate medical devices production to boost “make in India” for medical devices industry which is majorly import driven right now. We feel proud that 102 crore individuals received 220 crore COVID immunizations with the strong execution by government. It shows our robust healthcare strategy to address a major health catastrophe in a highly populated nation.

This year's budget included a National Digital Library for children and teens and a new pharmaceutical research and development plan. It was confirmed that researchers from public and private medical schools and commercial R&D teams will have access to lab space at several ICMR laboratories to promote joint research and innovation. Better research outcomes and new innovative solutions will result from these endeavors.

The Ministry of Health and Family Welfare, including the department of health research, obtained a financial rise to Rs. 89,155 crores in BE 2023-24 from Rs. 86,175 crores in BE 2022-23. A new initiative to assist scholarly research and innovative growth in the pharmaceutical industry will be unveiled this year. One of the genetic disorders that has been seriously hampering the health of the country, particularly among the indigenous peoples, is Sickle Cell Anaemia. We applaud this goal to eradicate this disease by 2047.

This year's budget places an excellent emphasis on skill development and addresses the industry's most critical challenges. The Aspirational Blocks Program, which covers 500 blocks to saturate vital government services, and the intention to construct three artificial intelligence centres of excellence, are evidence of other sector initiatives that contribute to healthcare. These initiatives will not only increase access to reasonably priced healthcare, but they will also do so with high predictability and better clinical outcomes.”

Shanay Shah, President, Shalby Hospitals

(DISCLAIMER: The views expressed are solely of the author and ETHealthworld does not necessarily subscribe to it. ETHealthworld.com shall not be responsible for any damage caused to any person / organisation directly or indirectly.)

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Thu, 16 Feb 2023 08:23:00 -0600 en text/html https://health.economictimes.indiatimes.com/news/industry/union-budget-2023-has-put-a-lot-of-emphasis-on-rd-and-basic-medical-education-shanay-shah/97584657
Killexams : NFLPA medical director guarantees Damar Hamlin will play professional football again

The question of Damar Hamlin's future in the NFL has loomed since he went into life-threatening cardiac arrest on the field last month, but one notable person is optimistic about the Buffalo Bills safety's chances.

NFL Players Association medical director Dr. Thom Mayer guaranteed that Hamlin will play on an NFL field again when asked Wednesday by a caller during an appearance on SiriusXM's Doctor Radio:

"I don't want to get into HIPAA issues, but I certain you, I certain you, Veronica, that Damar Hamlin will play professional football again," he said.

The exact cause of Hamlin's cardiac arrest remains unknown publicly, but the basic facts are that he collapsed on the field Jan. 2 after tackling Cincinnati Bengals wide receiver Tee Higgins. During the tackle, Higgins' shoulder made hard contact against Hamlin's chest.

Hamlin stood up after the tackle, then fell to the ground and remained motionless. He received immediate CPR and defibrillation from on-site medical personnel and eventually had his heartbeat restored. He was then rushed to nearby University of Cincinnati Medical Center, where he remained unconscious and on a ventilator for two days.

The 24-year-old Hamlin has steadily recovered since that terrifying night. He left Cincinnati on Jan. 9 and was back greeting his teammates within two weeks of his collapse. He has recovered enough that he was able to fly to Phoenix to take part in Super Bowl LVII activities, where he received the NFLPA’s Alan Page Community Award.

It has been stressed throughout this process that Hamlin has a long road to recovery ahead of him, but Mayer's comment might be the first time a person with medical knowledge and a direct connection to Hamlin has suggested that his road will lead to playing in the NFL again.

Hamlin, a sixth-round pick in the 2021 NFL Draft, had spent his career as a backup until early this season, when a season-ending neck injury to Pro Bowl safety Micah Hyde opened up a starting spot. Hamlin finished the season third on the Bills, with 91 total tackles, six tackles for loss, two passes defended, 1.5 sacks and 1 forced fumble.

Will Damar Hamlin play in the NFL again? The NFLPA's top doctor likes his chances. (Kirby Lee-USA TODAY Sports) © Provided by Yahoo Sports Will Damar Hamlin play in the NFL again? The NFLPA's top doctor likes his chances. (Kirby Lee-USA TODAY Sports)
Wed, 08 Feb 2023 10:46:00 -0600 en-US text/html https://www.msn.com/en-us/sports/nfl/nflpa-medical-director-guarantees-damar-hamlin-will-play-professional-football-again/ar-AA17gzHb
Killexams : Basic medical insurance funds to cover drugstore bills in China
People purchase medications at a pharmacy in Chongqing on Dec 16, 2022. [Photo by Cui Li/For China Daily]

BEIJING -- China is encouraging drugstores nationwide to integrate with the reimbursement system for outpatient services under the country's medical insurance schemes.

The move will enable those covered by medical insurance schemes to have their medicine bills incurring at drugstores reimbursed by medical insurance funds, according to a circular released by the National Healthcare Security Administration on Wednesday.

Medicines will need to be included in the medical insurance catalog and reimbursements will be made in accordance with local standards, said the circular.

Physicians from designated medical facilities can prescribe medication for patients for as long as 12 weeks to facilitate patients' purchase at drugstores, said the document.

It also urged healthcare security authorities to tighten oversight over the medical insurance funds and prevent and combat medical insurance fraud involving drugstores.

Thu, 16 Feb 2023 03:05:00 -0600 text/html https://www.chinadaily.com.cn/a/202302/16/WS63edf207a31057c47ebaf39e.html
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