Industry Seeks Clarity On FDA's Updated 510(k) Draft Guidance On Device Modifications

By Jof Enriquez,
Follow me on Twitter @jofenriq

Medtech industry groups are calling for the U.S. Food and Drug Administration (FDA) to clarify certain portions and language of its updated draft guidance for manufacturers looking to submit a 510(k) submission when making modifications to medical devices already on the market.

FDA meant to update the document in 2011, but withdrew it at the urging of Congress, who noted stiff opposition from industry. In August, FDA released the draft guidance, which mostly retains the basic format and content of the original guidance, along with industry feedback.

Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), said at the time that industry stakeholders and patient advocates helped FDA incorporate changes to the updated draft guidance in order to "strike the right balance between safety and effectiveness of modified devices and advancing device innovation."

But comments from stakeholder groups suggest that there is room for improvement over the discussion of pertinent topics in the draft guidance.

Regarding the role of Quality System Regulation (QSR) in changes to devices, FDA states in the document, "For some types of changes to a device, the Agency believes that a new 510(k) is not necessary and that reliance on existing QS [quality system] requirements may reasonably assure the safety and effectiveness of the changed device."

However, AdvaMed comments that FDA is not consistent throughout the draft guidance when it comes to applying risk management principles to assessing device changes, according to the Regulatory Affairs Professional Society (RAPS).

"At times, it is properly used; in many other places, it is missing entirely, and the Agency reaches a conclusion that a 510(k) is likely required, without much justification," writes Ruey Dempsey, VP of technology and regulatory at the Advanced Medical Technology Association (AdvaMed).

With regard to labeling changes, RAPS notes that federal regulation requires a new 510(k) submission for changes that either "could significantly affect the safety or effectiveness of the device," or when there is a "major change or modification in the intended use of the device."

However, AdvaMed and the Medical Device Manufacturers Association (MDMA) think that FDA's draft guidance seems to blend these test conditions into language that reads: "FDA interprets major changes in intended use to be a type of change that could significantly affect safety or effectiveness."

AdvaMed points out that FDA previously took the position that, when assessing whether a new premarket notification is needed, technology changes and intended use changes should undergo separate tests to determine if such changes warrant a 510(k) submission to FDA.