Resources External resources for medical device executives, sourced from the FDA’s website Food and Drug Administration Compliance Program Guidance Manual December 8, 2021 Deciding When to Submit a 510(k) for a Change to an Existing Device December 8, 2021 Guide to Inspections of Quality Systems December 8, 2021 Investigations Operations Manual 2021 December 8, 2021 Medical Device Tracking: Guidance for Industry and Food and Drug Administration Staff December 8, 2021
