Topic 13-FDA PDF

Topic 13 Chapter16 : Food and Drug Administration (FDA) and European Community’s (CE) 1)When designing any medical device, it is important to: consider all safety aspects, including the repercussions of design flaws and misuse of the device...

Topic 13 Chapter16 : Food and Drug Administration (FDA) and European Community’s (CE) 1)When designing any medical device, it is important to: consider all safety aspects, including the repercussions of design flaws and misuse of the device. 2) How does the regulation of medical devices protect consumer’s health and safety? by attempting to ensure that marketed products are effective and safe. 3) A medical device could be marketed without being: federally reviewed and approved. 4) When was the Food and Drug Administration (FDA) first authorized, and what period did Congress attempt to include devices until device laws were finally written? (FDA) was first authorized to regulate medical devices in 1938. From 1962, when Congress first attempted to include devices, until 1976 when device laws were finally written. 5) All devices were placed into classes based on? based upon the degree of risk posed by each individual device and its use. 6)What is The premarket notification process or 510(k)? is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval. 7) 510(k) and the premarket approval application (PMAA) became the regulatory pathways for device approval. 8)The investigational device exemption (IDE) became the mechanism to establish safety and efficacy in clinical studies for PMAAs. 9) How are Class I devices defined, and what are the implications of their failure? Class I devices are defined as nonlife sustaining. Their failure poses no risk to life, and there is no need for performance standards. 10) What basic standards are required for Class I devices? Basic standards, such as premarket notification or 510(k) process, registration, device listing, good manufacturing practices (GMPs), and proper record keeping are all required. 11) Has the FDA exempted any Class I devices from these requirements? Nonetheless, the FDA has exempted many of the simpler Class I devices from some or all of these requirements. 12) Can you give examples of Class I devices? For example, tongue depressors and stethoscopes are both Class I devices. 13) How were Class II devices defined in 1976? Class II devices were defined as not life sustaining. However, they must not only comply with the basic standards for Class I devices, but also must meet specific controls or performance standards. 14) give an example of a Class II device and its requirements? For example, sphygmomanometers, although not essential for life, must meet standards of accuracy and reproducibility. 15) What is premarket notification, and what purpose does it serve? Premarket notification is a documentation submitted by a manufacturer who notifies the FDA that a device is about to be marketed. It assists the agency in making a determination about whether a device is substantially equivalent to a previously marketed predecessor device. 16) How were Class III devices defined in 1976? and give examples? Class III devices were defined as either sustaining or supporting life so that their failure is life-threatening. For example, heart valves, pacemakers, and PCTA balloon catheters are all Class III devices. 17) What is usually required for Class III devices, and what challenges does this pose? Class III devices almost always require a PMAA, a long and complicated task fraught with many pitfalls that have caused the greatest confusion and dissatisfaction for both industry and the FDA. 18) What do the new regulations permit the FDA to do regarding PMA applications?  The new regulations permit the FDA to use data contained in four prior PMAs for a specific device that demonstrate safety and effectiveness, to approve future PMA applications by establishing performance standards or actual reclassification. 19) What additional requirements must be provided for PMAAs for Class III devices beyond the basic requirements for Class I and II devices? For PMAAs that continue to be required, all of the basic requirements for Class I and II devices must be provided, plus failure mode analysis, animal tests, toxicology studies, and human clinical studies directed to establish safety and efficacy under an IDE. 20) When must the preparation of the PMA for Class III devices begin? It is necessary that preparation of the PMA must actually begin years before it will be submitted. 21) What must every person engaged in the manufacture, preparation, propagation, compounding, or processing of a device do under section 510 of the act? Under section 510 of the act, every person engaged in the manufacture, preparation, propagation, compounding, or processing of a device shall register their name, place of business, and such establishment. 22) What does the FDA issue upon registration? the FDA issues a device registration number. 23) What must be communicated to the FDA device registration and listing branch within 30 days? A change in the ownership of the firm, the location, or person designated as the official correspondent must be communicated to the FDA device registration and listing branch within 30 days. 24) When must registration be done and how often must it be updated? when first beginning to manufacture medical devices and must be updated yearly. 25) What are the different types of 510(k) submissions, and how do their formats vary in addressing the requirements? 1. Submissions for identical devices 2. Submissions for equivalent but not identical devices  3. Submissions for complex devices or for major differences in technological characteristics. 4. Submissions for software-controlled devices 26) What is the purpose of the regulation governing PMA approval for Class III medical devices? to establish an efficient and thorough device review process to facilitate the approval of PMAs for devices that have been shown to be safe and effective for their intended use. 27) What does the regulation aim to achieve regarding the approval of PMAs for medical devices? The regulation aims to ensure the approval of PMAs for devices that have been demonstrated to be safe and effective for their intended use. 28) What is the regulatory focus concerning the disapproval of PMAs for medical devices? The regulatory focus is on disapproving PMAs for devices that have not been shown to be safe and effective or that do not otherwise meet the statutory criteria for approval. 29)What is the purpose of the IDE regulation? to encourage the discovery and development of useful devices intended for human use while protecting the public health. It provides the procedures for the conduct of clinical investigations of devices. 30) What does an approved IDE allow regarding the shipment and investigation of a device? An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with a performance standard or having marketing clearance. 31) What is the requirement for human research covered by federal regulation regarding funding? Any human research covered by federal regulation will not be funded unless it has been reviewed by an IRB. 32) What is the fundamental purpose of an Institutional Review Board (IRB) in relation to research activities?  To ensure that research activities are conducted in an ethical and legal manner. 33) What specific responsibility do IRBs have regarding informed consent in research? IRBs are expected to ensure that each of the basic elements of informed consent are included in the document presented to the research participant for signature or verbal approval. 34) What are the determinations that must result from the deliberations of the Institutional Review Board (IRB)? 1. Risks to subjects are equitable. 2. Selection of subjects is equitable. 3. Informed consent will be sought from each prospective subject or their legally authorized representative. 4. Informed consent will be appropriately documented. 5. Where appropriate, the research plan makes adequate provision for monitoring the data collected to assure the safety of the subjects. 6. Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.