Is Your Change Control Program Ready for FDA 510(k) Scrutiny?

A trio of FDA 510(k) guidances demonstrate how important it is for medical device manufacturers to get a firm grip on document management and change control – especially when working within the Third Party (TP) Review Program or trying to determine if a medical device change warrants a new 510(k). The agency is attempting to make it easier on device makers if they understand how to work within the new system. In other words, device makers without the means to quickly and easily produce high-quality documents might as well come back when they’re ready for prime time. Under the TP Review Program, TP Review Organizations conduct the equivalent of an FDA premarket review of a 510(k) submission, and then forward their reviews, recommendations and the submission itself to the agency. The FDA has recognized a number of TP Review Organizations and spelled out the list of eligible medical devices, generally low-risk and relatively simple ones. The September 12 guidance provides a high-level overview of the steps involved in how third-party reviews work:

  1. 510(k) registrant submits application to third-party reviewer
  2. Third-party review organization evaluates submission
  3. Third-party review organization submits recommendation to FDA
  4. FDA reviews third-party recommendation
  5. FDA issues review decision to third-party reviewer
  6. Third-party reviewer passes FDA decision on to registrant

It also spells out how TP Review Programs should determine that a device is eligible, prepare a submission, work with the FDA during the process and ensure the submission is complete. That’s where quality documents and management control enter the picture. If a submission is deemed insufficient by the FDA, the agency will expect the medical device manufacturer, via its TP, to demonstrate that it understands the FDA’s concerns and will provide a plan to remediate them. Essentially, the TP will go back to the device company to help it produce four critical pieces of information:

  1. A clear identification of the specific issue(s) or question(s).
  2. Acknowledgement of the information submitted and explanation of why the information provided did not adequately address the issue.
  3. Explanation of the relevance of the request for additional information to the substantial equivalence determination; and
  4. Recommendations regarding additional information needed to adequately address the issue or question and, when possible, suggestions of alternate ways to address efficiency.

FDA clarifies medical device change expectations

Meanwhile, the agency issued two other important guidances Aug. 8 designed to help device makers better understand when they need to submit a 510(k) for a change or software change to an existing device. Among other important issues, the software guidance stresses the importance of document control and integrity.

“The net effect of the [Quality System] regulation is to require that, when manufacturers of a finished medical device make a change in the design of a device, there is a process in place to demonstrate that the manufactured device meets the change in design specifications (or the original specifications, if no change was intended). They must keep records, and these records must be made available to an FDA investigator,” the agency reminds device makers. The agency also encourages device makers to keep quality management systems front of mind at all times. The good news is that, if a company has its ducks in a row, it may be able to avoid submitting a new 510(k) if its reliance on existing quality system requirements “reasonably assure the safety and effectiveness” of the changed device. However, it is incumbent upon device makers to remember that QMS regulations require that manufacturers of finished medical devices review and approve changes to device design and production. Looking at other device changes of a non-software nature, the agency reiterated its same demands regarding quality control documentation. Clearly, document control, change management and software management remain keys to keeping FDA regulators happy and better prioritizing which device changes require a new 510(k) and which don’t. Remember, however, that you must be prepared to demonstrate, via clear and robust documentation, that you had a strong and defensible rationale for your approach. If you can’t produce the right records relatively quickly in the event of FDA pushback, your situation is likely to get a whole lot worse before it gets better.

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