FDA updated recommendations for submitting 510(k) device modifications

This guidance provides clarity for minor changes that do not require FDA review.

Issue: October 2016

The FDA issued updated draft recommendations to help manufacturers determine when to submit a new 510(k) for device modifications.

“These draft recommendations are intended to help manufacturers determine when a change is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness,” Jeffrey E. Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review.”

New guiding principles

While manufacturers are required by federal law to submit a 510(k) when the safety, efficacy or intended use of an existing device could be significantly affected through changes or modifications, the new guidance aims to provide clarity for minor changes that do not require FDA review, as well as helps to ensure manufacturers appropriately submit modifications that do not require premarket review.

According to a spokesperson from the FDA, the specific revisions in the draft guidance include key issues previously addressed during interactions with stakeholders and submissions to the FDA following the release of the 2011 draft while maintaining the structure outlined in the 1997 guidance.

“These discussions have highlighted that certain vague terms in the 1997 guidance that should [be] clarified, as some decision-making points have raised questions among manufacturers about whether or not they are required to submit a new 510(k),” a FDA spokesperson told Orthopedics Today.

The current draft guidance recommends manufacturers to conduct a risk-based assessment to see if the change could significantly affect the safety and efficacy of the device, and each change should be assessed together and separately. Manufacturers should also comply with the quality system regulation, unless otherwise exempt, and describe all changes that would require a new 510(k) when a device is undergoing multiple modifications, according to the draft guidance. However, the FDA noted manufacturers are not guaranteed clearance on a new 510(k) for an existing device even with a complete and compliant submission. The overall intent of both draft and final guidance is to provide clarity and insight on the modifications that may necessitate a 510(k) submission, according to a spokesperson from the FDA.

Helpful change

The recommendations could be modified before the final guidance is released since the FDA is taking this time to collect and analyze comments from the industry, patient groups and other stakeholders, a spokesperson from the FDA noted.

“I have reviewed the draft guidelines, and in many ways I think it is only an advantage for us to have at this point because it provides various flow charts that might help crystalize how we need to think about 510(k)’s on changes in materials, changes in technology, changes in engineering of devices and changes in software that devices use,” Raj D. Rao, MD, professor and chairman of the Department of Orthopedic Surgery at George Washington University, told Orthopedics Today.

He added, “Overall, these are helpful and beneficial changes that provide more clarity into the FDA thought process and a greater degree of transparency.” – by Casey Tingle

Reference:
Deciding when to submit a 510(k) for a change to an existing device: Draft guidance for industry and Food and Drug Administration staff. Available at: www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM514771.pdf. Accessed Aug. 18, 2016.
FDA issues draft updated recommendations on submitting a new 510(k) for device modifications. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm515174.htm. Accessed Aug. 28, 2016.

For more information:
Raj D. Rao, MD, can be reached at George Washington University, 2300 M St., NW, 5th Fl., Washington, DC 20037; email: rrao@mfa.gwu.edu.

Disclosure: Rao reports no relevant financial disclosures.