FDA publishes Draft Guidance on the Documentation (510 k) of Medical Device Modifications

End of July, the FDA published a draft on the documentation of medical device modifications. This draft guidance for industry and FDA staff is entitled "510 (k) Device Modifications: Deciding When to Submit a 510 (k) for a Change to an Existing Device". In its finalised version it represents FDA's current thinking. From the 1976 enactment of the "Medical Device Amendments", FDA has attempted to define with greater clarity when a modification to an existing medical device would trigger the requirement that a new 510 (k) premarket notification be submitted. Basis is the regulation 21 CFR 807.81 (a)(3). According to FDA, the document leaves room for interpretation. The FDA Guidance dated 1997 "Deciding When to Submit a 510 (k) for a Change to an Existing 510 (k)" is not state-of-the-art anymore. When final, the draft will supersede this version.

The document is quite extensive with its 26 pages. It is divided into 9 chapters:

  • Introduction 
  • Background 
  • Scope
  • Basic Principles
  • Manufacturing Process Changes
  • Labeling Changes
  • Technology, Engineering, and Performance Changes
  • Materials Changes
  • Clinical Data

The interesting part starts in chapter 4 (Basic Principles). This chapter explicitly states that medical device modifications must always comply with Quality System Regulation (21 CFR 820) (unless the device in question is exempt from the QS regulation). This means that the modifications must be documented, validated or, where appropriate, verified prior to their implementation. The document explicitly requests the consideration of 21 CFR 820.30 (Design Controls) and 820.70 (Production and Process Controls). The following four chapters are a set of questions and answers. Changes in processes or device labeling, technology changes and materials changes are explained, sometimes with examples. The draft addresses for example changes in the expiration date, in sterilization, instructions for use, energy type, dimensional specifications, software, surface etc. Chapter 9 briefly explains the need for clinical data after modifications.

Conclusions: The draft elaborates, sometimes in detail, on the changes and their relevance. This could help industry to avoid uncertainties. But the document explicitly states that it is not all-inclusive since it cannot cover all possible changes. In the end, we must wait for the final document. Comments may be submitted until 25 October 2011.

You will also find more details in the Draft "510(k) Device Modifications" itself.

Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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