FDA Hits Snooze On Remanufacturing Draft Guidance, Cybersecurity Discussion Paper
The US agency is extending public comment periods for a controversial draft guidance and a cybersecurity servicing paper that caution servicers that they could get in hot water for remanufacturing medical devices.
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Software Servicers Can Help Keep Products On Market After Manufacturers Stop Providing Support: US FDA
The agency issued a discussion paper that lays out how third-party servicers could help mitigate cybersecurity threats and keep products on the market.
A new draft guidance from the US FDA clarifies what it considers to be remanufacturing. Companies remanufacturing devices are regulated by the agency and may require new premarket applications.
Digital Health Roundup, August/September 2021: Record Digital Health Funding Q1-3 Of $21.3Bn, AAOS Highlights, Regulatory Updates
In this roundup of developments in digital health, we highlight the key news and announcements from August and September.