Industry group opposes FDA proposal

SAN JOSE, Calif. – A medical electronics trade group opposes a proposal as currently defined by the U.S. Food and Drug Administration to create a Class IIb category of regulated medical devices. The new category is too broad and could create unneeded regulatory hurdles, said the Advanced Medical Technology Association (AdvaMed).

The FDA proposal is one part of a broad set of changes under discussion for the agency's 510(k) approval process used by thousands of medical devices each year. Medical device executives said at a recent event in Silicon Valley that the U.S. regulatory process has slowed down in the last two years due to a variety of factors.

AdvaMed proposed to the FDA in May it create a new class of regulated devices that use relatively new technologies or address new applications. However, the current proposal suggests "a more expansive set of device types" than AdvaMed supports, wrote Janet Trunzo, executive vice president for technology and regulatory affairs at AdvaMed in a letter to the agency.

The kind of broad new category the FDA proposal suggests "requires a statutory change" the Food, Drug and Cosmetic Act, she wrote.

In its May proposal, AdvaMed said the FDA should create a set of devices that are based on new technologies or applications that have not been well characterized. That list could be subject to additional regulatory requirements. Devices could be removed from the list as the technologies and applications become better understood, AdvaMed said.

The trade group suggested the products could be drawn from sectors such as implants and life-sustaining or -supporting devices.

At the recent event, one medical device executive said the implant sector is in an uproar about the new proposed IIb category."This puts us in a difficult position to raise funds or bring new products to market," said Kenneth Kleinhenz, vice president of regulatory affairs at Cytoritx (San Diego).

The FDA has published reports online covering proposed changes in medical device regulations. It also held an online event discussing the proposals.

In the online event, Jeff Shuren, who heads the FDA's medical devices unit, said the new category IIb is not intended as a way to require more clinical data from device makers. Rather, it is aimed to make the FDA process more clear about which devices require clinical data for approval.

The public review period of the 510(k) proposals ends October 4. The FDA has not given an exact time when it will release its decisions about changes to the process, but suggested they will be phased in over time.