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Regulatory Focus™ > News Articles > US FDA Proposes Changes to MedWatch Program for Healthcare Products

US FDA Proposes Changes to MedWatch Program for Healthcare Products

Posted 04 June 2015 | By Stewart Eisenhart

US FDA Proposes Changes to MedWatch Program for Healthcare Products

Content provided by Emergo, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.

US drug and medical device market regulators are proposing changes to voluntary and mandatory post-market reporting forms used by consumers and healthcare providers for adverse events related to medical products.

The Food and Drug Administration is seeking comment through July 1, 2015 on changes to three reporting components of its MedWatch system:

  • Form 3500 for voluntary reporting by healthcare professionals of serious adverse events and product issues for medical devices, drugs, some biologicals and cosmetic products
  • Form 3500B for voluntary reporting by consumers for drugs, medical devices, nutritional products and cosmetics
  • Form 3500A for mandatory reporting by, in the case of medical devices, manufacturers and importers as well as reprocessors of single-use devices of any adverse events, deaths or serious illnesses or injuries related to their devices

The FDA’s proposed changes to these forms consist primarily of formatting modifications, but healthcare providers and device manufacturers should nonetheless be aware of pending changes to these reports—especially the mandatory Form 3500A, obviously—to ensure ongoing compliance with US postmarket reporting requirements.


Original Post at Emergo

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