On July 27, 2011, the Food and Drug Administration (“FDA” or “Agency”) released a draft guidance document for manufacturers regarding when to submit a premarket notification submission (510(k)) for changes or modifications made to a previously cleared medical device. When final, this guidance will supersede a guidance document that FDA issued in 1997 (Deciding When to Submit a 510(k) for a Change to an Existing Device), and serve as an important development in FDA’s continuing effort to strengthen the Agency’s 510(k) program.

As background, under current FDA regulations, a manufacturer is not required to submit a new 510(k) for a device modification unless the modification “could significantly affect the safety or effectiveness of the device” or there has been a “major change or modification to the intended use of the device.” 21 C.F.R. § 807.81(a)(3). These regulations allow manufacturers to make incremental or so-called “minor” modifications to devices on the market that are immaterial to safety and effectiveness, without undue regulatory burden. 

FDA’s new draft guidance – 510(k) Device Modifications:  Deciding When to Submit a 510(k) for a Change to an Existing Device – reflects the Agency’s current thinking on device changes and emphasizes the most important factors in determining whether to submit a 510(k) for a device modification. Among other things, the draft guidance includes a new section for manufacturing process changes, discusses nanotechnology, contains new questions to help guide manufacturers, and is full of detailed examples. The draft guidance highlights common changes to devices that would require a new 510(k), and changes that could simply be documented without the submission of a 510(k) in accordance with a manufacturer’s existing Quality System without prompting the need for a new 510(k) submission. 

The draft guidance also addresses numerous concerns raised in August 2010 by FDA’s 510(k) Working Group, which was convened in September 2009 as part of a two-pronged, comprehensive assessment of the 510(k) process. The Working Group expressed concerns about faulty beliefs and assumptions held by the industry about device modifications, including, among other things, concerns that:

  • Manufacturers were misinterpreting federal regulation to mean that a new 510(k) is only necessary if a modification definitively does affect safety and/or effectiveness. In actuality, the regulation, 21 C.F.R. § 807.81(a)(3), requires a new 510(k) for any change or modification that “could significantly affect” either the safety or the effectiveness of a device. Whether a change could significantly affect the safety or effectiveness of a device is one of the key issues the new draft guidance tries to address. 
  • Manufacturers were misinterpreting the regulation to mean that a new 510(k) is only necessary if a modification could significantly negatively affect safety and/or effectiveness. The Working Group was concerned that manufacturers did not appear to appreciate that device changes intended as improvements to a device’s safety or effectiveness could also significantly affect safety or effectiveness and require a new 510(k).
  • Manufacturers did not understand what types of manufacturing process changes might warrant the submission of a new 510(k).

Although we are still assessing the contents and implications of the document, FDA’s new draft guidance appears to be a step in the right direction, and one that, if it becomes a final guidance document, would help to improve FDA’s 510(k) program – a program that has been slow to adapt to the evolving complexity of medical devices. 

Please note that Reed Smith attorneys are currently preparing a comprehensive analysis of the new draft guidance. Our analysis will be posted on this blog and the Reed Smith website within the next few days. FDA is accepting electronic or written comments on the draft guidance until October 25, 2011 (identified by Docket No. FDA-2011-D-0453).