Why Should You Attend:
With the release of the finalized Medical Device Reporting (MDR) guidance on November 8, 2016, FDA has taken several positions that are in direct contrast to their previous opinions on the subject. Firms face new scrutiny from FDA on their complaint handling and reporting efforts. One of the top 3 inspection observations on an FDA 483 is lack of compliance with 21 CFR 803 (i.e., Medical Device Reporting), failure to make MDR determinations correctly and in a timely manner resulting in a large percentage of the Warning Letters issued by the FDA to US and Foreign manufacturers.
The MDR final guidance document itself is not an easy read, with 50+ pages of material outlining new positions that manufacturers consider when providing reporting obligations.
Manufacturers of Medical Devices are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction was to be reoccurring. But, most manufactures do have a full understanding of what “Becomes Aware” meaning.
This 90-minute interactive webinar that will simplify the regulation and get grip on the final guidance. It will give you the tools to remain compliant or build top-notch compliance protocols.
Areas Covered in the Webinar:
Who Will Benefit:
This course will be valuable to anyone involved in medical device complaint handling and MDR reporting, including everyone from phone teams, engineers, quality and compliance personnel, regulatory affairs, and upper management.Instructor Profile:
Rita Hoffman is the Principal Consultant/Owner of Regs & Recall Strategies, LLC, and a consulting firm providing regulatory insight focusing on industry assistance on FDA compliance issues. Ms. Hoffman has been consulting with FDA firms on post marketing issues for the past 6 years.
Ms. Hoffman spent more than 37 years with the FDA prior to retiring in 2011 she was the recall branch chief for the Center for Devices and Radiological Health (CDRH). She was responsible for oversight and review of all medical devices recalls with extensive knowledge of the legal authority of 21 CFR Parts 7 & 806, 803 and 820 of the Act. During Ms. Hoffman’s tenure with FDA, she served in several critical headquarter positions including: compliance officer, ombudsman, jurisdictional review officer, small business liaison, and policy analyst.
Ms. Hoffman has a diversified knowledge encompassing FDA scientific, investigational and regulatory policy and compliance areas due to her in-depth understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. Throughout her FDA career, she has provided guidance and clarified FDA requirements, to industry, foreign governments, public entities and FDA field personnel involving recalls, labeling issues, dietary supplements, pharmaceuticals, OTC drug products and combination products.
Ms. Hoffman, in addition to RAPS Certified, is the recipient of RAPS Special Recognition Award for her unique contributions and achievements of individuals and organizations that advance the quality of health and regulatory affairs. She served as co-chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter for 2-terms, working in collaboration with both chapter members and FDA to increase professional awareness of regulatory issues. Ms. Hoffman holds a BS from the University of Maryland and has received many additional awards from both government and industry including the FDA Distinguished Government Service Award and Outstanding Service Awards for her Compliance work and industry contributions.
What are MDR’s?:
Medical Device Reporting under 21 CFR 803 establishes the reporting requirements for device user facilities, manufactures and importers. It is a mechanism for the Food and Drug Administration to identify and monitor significate adverse events involving marked medical devices.
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