We also look inside a new draft guidance from CDRH that would update the way software is documented in pre-market submissions.
Lastly, we distill some key points from a recent warning letter issued to…
Free Sample Issue: Another Take on FDA's Remote Inspection Authority for Devices, Updates to Software Documentation in Pre-Market Submissions + GMP Warning Letter Breakdown
We dive deeper into expanding FDA's authority to remotely review device companies, outline changes to pre-market submissions for devices with software, and look at trending GMP issues.
The FDA Group's Insider Newsletter
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The FDA Group