Best Practices for Medical Device Reporting (MDR) Under FDA’s Final Guidance
On November 8, 2016, FDA released its long-awaited final guidance document, “Medical Device Reporting for Manufacturers” (Final Guidance), which explains and clarifies FDA’s interpretations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping for manufacturers. The Final Guidance supersedes the Medical Device Reporting for Manufacturers final guidance published in March 1997, and replaces FDA’s draft guidance on Medical Device Reporting for Manufacturers published on July 9, 2013. The Final Guidance contains significant policy changes that will affect how device manufacturers carry out their MDR reporting obligations. This webinar will:
- Provide an overview of the key provisions of the Final Guidance and their impact on manufacturers’ MDR reporting practices.
- Discuss current FDA enforcement trends in the area of MDR reporting.
- Recommend steps that manufacturers can take to avoid common MDR reporting pitfalls.
- Provide an overview of FDA’s final regulation on safety reporting for combination products, and discuss the relationship between that regulation and FDA’s Final Guidance on MDR reporting.
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
Pamela F. Forrest
Covington & Burling LLP
Pamela Forrest has over 20 years of experience in advising clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, establishment registration and device listing, labeling and promotion, import/export issues, and clinical trial requirements. Ms. Forrest frequently advises medical device manufacturers on responses to FDA enforcement actions, including Form FDA-483 observations and Warning Letters. She works closely with technical quality system experts to draft written responses, advise on corrective actions, and prepare manufacturers for re-inspection. Ms. Forrest has extensive experience in assisting medical device manufacturers, investment banks, and private equity firms with complex due diligence evaluations regarding the FDA compliance status of acquisition targets.
Scott D. Danzis
Covington & Burling LLP
Scott Danzis is a partner in the firm’s Food & Drug and Health Care practice groups. His practice focuses primarily on the regulation of medical devices, but also includes regulation of drugs, biologics, and tobacco products. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements, postmarket reporting, recalls, and enforcement actions.