Tag Archives: DHR

Devine Guidance

Accurate DHRs are Never Optional

By Dr. Christopher Joseph Devine

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.

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.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Device History Record

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

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.

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