Wednesday 10th April, 2013
10:00am to 11:30am
Overview: Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. If you are a consumer or health professional you should use the MEDWATCH program for reporting significant adverse events or product problems with medical products.
Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous reports have shown there is widespread underreporting. On July 31, 1996, the new Medical Device Reporting (MDR) regulation became effective for user facilities and device manufacturers. The statutory authority for the MDR regulation is section 519(a) of the FFD&C Act as amended by the Safe Medical Devices Act (SMDA) of 1990.
Areas Covered in the Session:
What form should I use to submit reports of individual adverse events and where do I obtain these forms?
How will I know if I require more information about my medical device report?
Reporting device-related deaths and serious injuries and when these are not treated as a product complaint
Understand the manufacturer's reporting requirements and expectations
Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
Learn what constitutes a MDR and how to facilitate this for compliance success
Develop, maintain, and implement written MDR procedures and achieve compliance
Learn why FDA is amending its MDR regulations to remove a requirement for baseline reports that the agency deems no longer necessary
Who Will Benefit: This webinar will provide valuable assistance and guidance to all medical device companies and user facilities that are required to manage or comply with the provisions of the 21 CFR 803 MDR program. The employees who will benefit include:
All levels of Management for all departments and those who desire a better understanding or a "refresh" overview
Regulatory Affairs and Compliance
David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices and managing and handling activities within the global regulatory and compliance landscape.
Livermore Common, Fremont, CA, 94539
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10th April 2013