With digitalization impacting all areas of manufacturing operations, it should come as no surprise that medical device producers must adapt or risk missing the next wave of performance and product improvements.
The FDA wants to know that rework activities are not impacting product safety and efficacy issues or influencing long-term product reliability.
The DMR is nothing more than the recipe (a.k.a. secret sauce), while the DHR is documented evidence of compliance.
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.