BTRA 641 UMGC Product Life Cycle Discussion

by | Mar 5, 2023 | Science

Description

  1. What are the three general problem areas with labeling FDA has encountered?
  2. What are the exemptions from labeling for IVDs?
  3. How long does an applicant/sponsor have to report an adverse drug experience? What are the procedures for an applicant/sponsor after submitting an ‘Alert Report’?
  4. Approximately how many generic types of medical devices of FDA recognize? How many medical specialties are these devices grouped into?
  5. What is/are the difference(s) between premarket approval and 510(k)?
  6. What are the criteria for determining if a manufacturer of a medical device must conduct postmarket surveillance?
  7. What type of post-market studies can FDA require?
  8. When are annual reports required for an ANDA and an NDA?
  9. When are annual reports required for a BLA?
  10. If a company is marketing a device and it wants to use the same device for something else, what kind of application must the company file?
  11. What information from medical device reports (MDR) can FDA disclose to the public?
  12. What responsibility do manufacturers have with regard to keeping copies/records/files of MDRs?
  13. Does a manufacturer need to provide FDA with a postmarket surveillance plan? If so, does it need approval before it can be enacted?
  14. When is it best to file an ANDA instead of an NDA?
  15. According to the FDA, what are the requirements for submitting a BLA?
  16. Does an IND have to be filed before a BLA? If so then why?
  17. What types of records are manufacturers/sponsors/investigators required to keep during the postmarket surveillance period?
  18. Is postmarket surveillance ever required for a class I medical device? What about class II?
  19. What law does the FDA use to take legal action against regulated products? And how does it define a ‘label’?
  20. Generally, what is the approval process for vaccines?
  21. According to the FDA, what are the goals of the NDA?
  22. Is advertising considered part of labeling?
  23. What are the requirements for labeling the immediate container of IVDs?
  24. Is there a specific language labeling should be written in?
  25. What are the requirements for the labeling of inserts and outer packaging? Please add reference list in APA style

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