Last week, FDA held a public meeting to solicit stakeholder input to inform FDA’s development of both a report to Congress and, ultimately, a new policy on when a 510(k) should be submitted for a modification to a cleared device.  We described the purpose and goals of FDA’s public meeting in an earlier post.

At the June 13 public meeting, industry and consumer groups expressed differing views about the appropriate role for manufacturers in deciding when to submit a new 510(k) for a modified device.  For example, AdvaMed reiterated the position set forth in its white paper (released the day before the public meeting) that the manufacturer is best qualified to determine whether a change “could significantly affect the safety or effectiveness of a device,” thereby meeting the regulatory standard for submission of a new 510(k).  Industry groups, such as AdvaMed and the Medical Device Manufacturers Association, argued that a new regulatory approach was not needed.  Instead, AdvaMed recommended that FDA make only modest changes to address concerns with the 1997 memorandum, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” by making the following modifications:

  • require manufacturers to evaluate device changes in accordance with an established procedure and retain records detailing how they evaluated whether a premarket submission was needed for a device change;
  • establish a procedure within their quality systems to ensure design changes before and after production of the device are reviewed, validated (or verified where appropriate) and approved; and
  • indicate that manufacturers should document how the decision was made based on validation or verification testing (if applicable) in compliance with the QSR requirements.

In contrast, some consumer groups, such as the National Research Center for Women and Families, argued that FDA, not device manufacturers, should determine whether a new 510(k) is required for a device modification.  Such groups did not support keeping the 1997 memorandum, and instead advocated for FDA to issue a new guidance.

At the meeting, FDA indicated that changes to the 1997 memorandum were necessary, for example, to keep up with new technologies, such as wireless or Bluetooth.  But the agency noted that change might not happen quickly because some proposals might require regulatory or legislative action to implement.  FDA noted that it will continue to seek stakeholder input on this issue.

The webcast of the public meeting is available on the FDA website and the agency is accepting written comments until July 13, 2013.