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Compliance In Focus
Posted by John Lehmann on Mon, May 6, 2013

510(k) Device Modifications - FDA Summer Workshop

On April 30, 2013, FDA announced a workshop titled “510(k) Device Modifications: Deciding510(k) Device Modifications When to Submit a 510(k) for a Change to an Existing Device” scheduled for June 13, 2013. The main purpose of the meeting is to discuss the agency’s past, present, and future policy on 510(k) modifications. The FDA is inviting external stakeholders to provide discussion and bring examples of actual device modifications to use in developing future policy.

The following have been identified as discussion items:

  • Use of risk management to determine if device modifications require a new 501(k)
  • Design control and the relationship to pre-market evaluation
  • Potential use of critical specifications to determine if modification requires a new 510(k)
  • Potential risk-based stratification for 510(k) modification purposes
  • Incorporating periodic reporting

The public is invited add to the discussion by submitting comments for review during the meeting by May 30, 2013. All other comments related to meeting will be accepted until July 13, 2013.

Currently, in 21 CFR 807.81(a)(3)1, a new complete 510(k) application is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device, or the device is to be marketed for a new or different indication.

As described on http://www.fda.gov/“When a 510(k) holder decides to modify an existing device, the holder must decide whether the proposed device modification(s) requires submission of a 510(k). It is not FDA's intent that a 510(k) must be submitted for every modification. However, all changes in indications for use require the submission of a 510(k). A change in indication for use includes prescription use to over the counter use. Deciding When to Submit a 510(k) for a Change to an Existing Device2 provides guidance to 510(k) holders on deciding when to submit a 510(k) for a change to an existing device.”

Are you planning on commenting on the FDA’s website to add to the discussion on June 13, 2013? What changes do you anticipate seeing to currently policy as a result of the meeting? Please provide comments below.

Photo Credit: chrisinplymouth

510(k) Current Status and Considerations

Topics: Medical Devices, FDA, 510(k)


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