In the inaugural episode of our new deep-dive podcast Speaking Of Medtech, former US FDA device center compliance chief Steve Silverman and Medtech Insight executive editor Shawn M. Schmitt discuss remote facility inspections and question whether they’re the wave of the future.
Medtech Insight articles addressing topics discussed in this episode:
• Come On In, The Water’s Fine: FDA Should Fully Embrace Remote Inspections
https://medtech.pharmaintelligence.informa.com/MT144289/Come-On-In-The-Waters-Fine-FDA-Should-Fully-Embrace-Remote-Inspections
• Enforcement Comeback? FDA Predicts 1,767% Increase In US Inspections In FY ’22, Matching Pre-Pandemic Levels
https://medtech.pharmaintelligence.informa.com/MT143997/Enforcement-Comeback-FDA-Predicts-1767-Increase-In-US-Inspections-In-FY-22-Matching-PrePandemic-Levels
• To RRA, Or Not To RRA? BD Talks Decision-Making Around FDA Requests For Remote Regulatory Assessments
https://medtech.pharmaintelligence.informa.com/MT144053/To-RRA-Or-Not-To-RRA-BD-Talks-DecisionMaking-Around-FDA-Requests-For-Remote-Regulatory-Assessments
• ‘We Were A Victim’: How An FDA Remote Regulatory Assessment Took One Device Maker By Surprise
https://medtech.pharmaintelligence.informa.com/MT143998/We-Were-A-Victim-How-An-FDA-Remote-Regulatory-Assessment-Took-One-Device-Maker-By-Surprise
