Posted 14 November 2016
By Michael Mezher
Prominent medical device manufacturers and industry groups are calling on the US Food and Drug Administration (FDA) to make changes to its recently released draft guidance on submitting a new 510(k) for changes to a medical device.
FDA released the draft guidance last August, five years after the agency's controversial first attempt to replace its existing guidance in 2011. However, FDA withdrew its 2011 draft guidance after Congress ordered the agency to rethink its policies in light of strong industry opposition. At the time, industry felt FDA's 2011 draft would increase the number of changes that would require a new 510(k).
While industry groups the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA) say they are supportive of the new draft guidance, with MDMA calling it a "significant improvement" over the 2011 version, both groups say there are issues and inconsistencies that must be addressed.
Quality System and Risk Management
In the draft guidance, FDA says it recognizes that the Quality System Regulation (QSR) plays a role in mitigating risks for certain device changes.
"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," FDA writes.
However, in its comments, AdvaMed says FDA is not consistent throughout the draft guidance when it comes to applying risk management principles to assessing device changes.
"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, vice president of technology and regulatory at AdvaMed.
Both AdvaMed and MDMA say they are concerned about FDA's approach to labeling changes in the draft guidance.
Under federal regulations, device makers are required to submit a 510(k) when a change to a device "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."
Both groups say that FDA's language in the draft guidance appears to blend these two "tests" when it comes to labeling changes. "FDA interprets major changes in indented use to be a type of change that could significantly affect safety or effectiveness," FDA states in the draft guidance.
However, AdvaMed says that in the past, FDA has "clearly recognized that technology changes required a test to determine if such changes require a new premarket notification and intended use changes likewise required a separate test to determine whether a change in intended use may result in a new device classification, thus the need to submit a new premarket notification for FDA's consideration."