Device reporting was enacted by Congress to increase the information FDA and manufacturers receive about problems with medical devices although manufacturers and importers of medical devices have been required since 1984 to report issues. Under the Safe Medical Devices Act of 1990 (SMDA), device user facilities must report issues, injuries and deaths to FDA and manufacturers.
Let our expert presenter Dr Kosta Makrodimitris help you understand the Medical Device Reporting (MDR) and what are the FDA requirements for importers, manufacturers, hospitals and consumers. This power packed webinar will provide the current and expected policies for Medical Device Reporting (MDR) in US.. The MDR regulation (21 CFR 803) contains mandatory requirements for manufacturers, importers and user facilities to report medical device adverse events.
Our expert will explain what are the current policies and guidances (1984-current, FDAMA), update on upcoming regulations and discuss what industry, hospitals and patients should know and how to conform to MDR rules.
Relevant MDR initiatives and standards in US will be explored and the audio conference will present an overview of the global regulations and cases in the field. Here are the tools you’ll walk away with:
Here are few topics covered in the session:
Who should attend?
- Dr. David Lim
Dr. Kosta Makrodimitris, PhD, CF-FDA, CP-EHR, is Biomedical/Health Informatics Advisor, Author & Strategist. He is certified on EHR/PHR, Clinical Trials, Biotech/Drug Development, and trained in US FDA/DHHS laws, regulations (medical devices, foods, drugs, personalized medicine, health IT). He is involved as: