FDA recently announced a public meeting to be held on June 13, 2013 on when a new 510(k) must be submitted for a modification to a cleared device. The meeting is intended to solicit stakeholder input to inform FDA’s development of both a report to Congress and, ultimately, a new policy on this critically important topic.
This issue has a long history. FDA’s regulations provide that a 510(k) is required for “significant changes” to a device, including a change that could “significantly affect the safety or effectiveness of the device,” and “a major change or modification in the intended use of the device.” If the manufacturer concludes that a new 510(k) is not required, the manufacturer must document the change to the device and the basis for its conclusion in a memorandum to file.
In 1997, FDA issued a memorandum entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device,” to provide guidance to manufacturers. Although this guidance provided some useful insights on when a new 510(k) was necessary, the document left many questions unanswered. Thus, in July 2011, FDA issued a draft guidance entitled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to An Existing Device” that was intended to replace the 1997 guidance when finalized. The 2011 draft guidance made a number of substantive changes to FDA’s existing policy, which, if implemented, would result in FDA requiring more 510(k)’s to be submitted to the agency. For example, modifications to cleared devices that previously could have been addressed by a letter to file, such as changes to promotional labeling or certain technological changes to a device, might now require a new 510(k).
Industry noted that the changes proposed by FDA in the 2011 draft guidance would have resulted in a dramatic increase in the number of 510(k) submissions required, which would have imposed a significant burden on manufacturers and unnecessary delays in the introduction of improvements to existing devices. Additionally, CDRH’s’s review team would be burdened with the increased number of submissions, creating a backlog of applications and slowing the device regulatory process.
Last summer, Congress revoked FDA’s 2011 draft guidance in section 604 of the Food and Drug Safety and Innovation Act (FDASIA). FDASIA provides that the 1997 guidance shall be in effect until the agency issues new guidance or proposed regulation on the topic. But FDA cannot issue a new regulation or guidance until the agency submits a report to the House of Representatives Committee on Energy and Commerce and the Senate Health, Education, Labor and Pensions Committee. The report is due to Congress by December 9, 2013. The input gathered in connection with this public meeting will be used to draft the congressional report and, ultimately, a new guidance or regulation.
If you are interested in attending or making a presentation at the workshop, you must register by May 30. The workshop will also be live webcast if you cannot attend in person; registration is required. FDA is accepting written comments until July 13, 2013. Comments that are submitted by May 30, 2013 might be discussed at the meeting.