Updates on Medical Device Post-Market Reporting Regulations
1 Hour and 20 Minute Video | Jeffrey K. Shapiro, Hyman, Phelps, and McNamara, P.C.
Medical device reporting is one of the most common post-market surveillance activities required of all medical device manufacturers in accordance with the Medical Device Reporting (MDR) regulation (21CFR 803). The FDA requires device companies to account for certain instances of adverse events and product problems in order to ensure safety issues can be identified and addressed quickly. The FDA recently revised MDR policies and published a final rule stating that manufacturers must submit MDRs in an electronic format, which is aimed at improving the FDA’s process for collecting, reviewing, and archiving adverse event information. It is essential for device manufacturers to fully understand and prepare for these changes as the rule will go into effect on August 14, 2015.
- MDR overview focusing on current trends and interpretations
- Summary of mandatory reporting requirements for manufacturers
- Navigating through MDR grey areas
- Product versus satisfaction complaint
- Device repair versus complaint
- Additional noteworthy guidance in final rule
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Medical Device Reporting
- Post-Market Surveillance
- Quality Systems
This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.
Jeff Shapiro is a partner in the law firm of Hyman, Phelps & McNamara (Washington, DC). For 20 years, Mr. Shapiro has represented medical device companies before the Food and Drug Administration (FDA). He assists in both premarket and postmarket compliance matters. Mr. Shapiro also has expertise in combination products and FDA’s regulation of human tissue based products (361 HCT/Ps). Mr. Shapiro is on the Editorial Advisory Board of MDDI and Update magazines. He is also a frequent speaker at medical device and diagnostic seminars and conferences. Mr. Shapiro is a graduate of Brown University (magna cum laude) and the Harvard Law School (cum laude).
His areas of medical device expertise include: Developing premarket regulatory strategy for products, assistance with IDE, 510(k), and PMA submissions, advice in MDR, recall (field action) and QSR compliance matters, review of labeling and advertising for compliance, regulatory due diligence and post-acquisition risk mitigation, reviewing contracts and security disclosure documents and responding to 483s and warning letters.