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Have a device correction or removal? Not sure what’s required when reporting?
FDA’s Medical Device Recalls FAQ covers Part 7 and Part 806 requirements – from what triggers a report to what info must be included.
fda.gov/media/170726/d…
Medical Device Manufacturers. Refer to this list of useful information prior to submitting recall information. Here you will find Form 5072 and FAQs specific to medical device recalls.
Using Form 5072 helps ensure your medical device recall submission includes everything FDA
Use FDA Form 5072 to ensure your medical device recall submission is complete.
FDA is encouraging device manufacturers to consider using FDA Form 5072, “Device Correction and Removal Report,“ when submitting required information for voluntary recalls.
Join us on Thursday July 30th from 9:30 a.m.–4:50 p.m. ET for a Public Meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee discussing Replimune’s BLA for vusolimogene oderparepvec, in combination with nivolumab, for advanced melanoma. youtube.com/live/7x4xuKJti…
