It remains unclear how FDA will move forward with its most controversial 510(k) reform proposals, such as creating a separate class IIb category for more complex devices, with mixed messages from the agency on whether the proposals are still on the table.

During closed-door user fee negotiations Aug. 9, FDA assured industry representatives it has “no current plans” to implement the seven most controversial 510(k) reform recommendations it first proposed in its August 2010 preliminary 510(k) report and later punted to the Institute of Medicine for input.

“Industry asked FDA to comment on workload impacts of the seven items that FDA referred to IOM,” the meeting minutes, released last week, state. “FDA replied that there are no current plans to implement these recommendations.”

But publicly, FDA is indicating that the jury is still out on class IIb. The agency will announce its plans regarding that and the other controversial recommendations by the end of October.

“Regarding class IIb … we have not yet made an official decision,” an FDA spokeswoman told "The Gray Sheet" Sept. 22. “We intend to announce by the end of October what we plan to do regarding both the IOM's recommendations and those recommendations from our reports we had deferred a decision on to allow the IOM to weigh in on if they so chose.”

Are These Proposals Toast?

FDA next month will announce its plans for its most controversial 510(k) reform recommendations, including proposals to:

Consolidate the terms "indication for use" and "intended use" into a single term
Expand CDRH's statutory authority to consider off-label use when determining the intended use of a device
Issue guidance on when a device should no longer be available for use as a predicate
Issue a regulation on 510(k) rescission authority
Require manufacturers to keep one unit of a device available for FDA testing
Issue guidance to create a class IIb category
Seek greater authorities to require post-market studies as a condition of clearance for certain devices

Industry has been pressing FDA to drop the seven controversial recommendations and focus on 510(k) program improvements that have more general support. (See “ Also see "Massachusetts Device Makers Urge FDA To Abandon Controversial 510(k) Reform Proposals" - Medtech Insight, 18 July, 2011. ” – “The Gray Sheet” July 18, 2011.)

To the surprise of many, the IOM did not end up addressing the seven recommendations when it issued its 510(k) assessment in July; instead, the institute urged FDA to replace the 510(k) program altogether. (See “ Also see "Institute Of Medicine On 510(k) Review Program: Dump It" - Medtech Insight, 1 August, 2011. ” – “The Gray Sheet” Aug. 1, 2011.)

One IOM committee member, attorney William Vodra, recently suggested it is not worth spending FDA resources on some of the agency's proposals, including establishing a separate class IIb and identifying predicates that should no longer be used in the 510(k) clearance process.

“AdvaMed agrees with the IOM committee’s decision to not weigh in on the seven additional recommendations for which FDA requested feedback,” Janet Trunzo, executive vice president for technology and regulatory affairs, said during a Sept. 16 public meeting on the IOM recommendations.

“We fully agree with a recent statement by an IOM committee member not to spend scarce FDA resources on studying or implementing any of these seven recommendations,” Trunzo said.

No Plans To Redefine Intended Use

During the Aug. 9 user fee discussions, FDA specifically affirmed that it has no plans to consolidate the terms "indication for use" and "intended use" into a single term, another one of the seven outstanding proposals.

“The forthcoming 510(k) paradigm guidance document retains both distinct concepts and terms,” the agency relayed in the meeting minutes.

By Jessica Bylander

Will Class IIb See The Light Of Day? FDA Sends Mixed Messages

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