Can your company prove its device has been manufactured in accordance with its DMR?
When it comes to compliance, the FDA does not grant special dispensation.
Documented evidence of compliance is your best friend during an agency inspection.
Get an instant warning letter with repeat Form 483 observations.
When your friends from the agency stop by for that friendly cup of coffee and an inspection, they will ask to see DMRs and, eventually, review DHRs to verify finished medical devices are being properly manufactured.
FDA feels so strongly about the importance and composition of the DHR, that the Quality System Regulation (21 CFR, Part 820) contains a section dedicated to this.
In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.184 (Device History Record). The Device History Record (DHR) is a collection of activities such as production routers, as-built configurations, test and inspection results, copies of labeling, etc., retained for a specific device or batch of devices. Device manufacturers can take it to the proverbial bank: DHRs will be scrutinized during a routine inspection.