FDA plans to implement recommendations from an internal 510(k) task force within months, Office of Device Evaluation Director Donna Bea Tillman said in a Sept. 25 memo to staff.

The center-wide 510(k) working group was established to look at ways of strengthening the 510(k) program. In addition, FDA has asked the Institute of Medicine to conduct an intensive review of the 510(k) system and report back by 2011 (¹ Also see "FDA Asks Institute Of Medicine To Evaluate 510(k) Review Process" - Medtech Insight, 28 September, 2009.).

Tillman said she wants to get a "better handle" on the 510(k) challenges that the various CDRH divisions face, particularly when determining whether a new device represents a new indication for use compared to previous technologies.

The office director is asking her ODE branch chiefs to alert her anytime she receives a new 510(k) for a never-before-cleared indication in that device type.

ODE also plans next year to update guidance on when to submit a new 510(k) for changes to an existing device. The 1997 "510(k) modifications" document provides a general guide to companies deciding whether or not to file a new 510(k) for changes to existing products - such as changes to labeling, technology, performance specifications or materials. The policies recently have faced some scrutiny (² Also see "FDA Policy For Device Modifications Faces Mounting Scrutiny" - Medtech Insight, 6 July, 2009.).

"These are just the first of what I am sure will be many things that we will be doing to strengthen the 510(k) and all of our other programs in the months ahead," Tillman told staff.

Attention on the 510(k) program has intensified over the past year; most recently, an internal FDA examination of a controversial 510(k) product clearance decision pointed out cracks in the underlying regulation (see ³ Also see "ReGen Challenges FDA Report's Facts And Motivation" - Medtech Insight, 5 October, 2009.).

But D.C. attorney Arnold Friede says FDA's scrutiny of its program does not go far enough.

The 510(k) process was established in the 1976 Medical Device Amendments as a way of leveling the playing field between devices on the market before 1976 - which were grandfathered into FDA's system without immediately undergoing additional review - and products marketed after 1976, which would be subject to FDA review.

Friede, who runs the firm Arnold Friede & Associates, says the program "was never intended, at least at the outset, to be an enduring feature of the medical device review and approval process."

"Hopefully the IOM [report] will really get into the underlying justification for the 510(k) process and whether or not that justification holds true," he said.

In the meantime, Friede says the report is likely to make FDA review staff "very, very cautious."

"It's probably going to slow the clearance process down," he said.

"There's an explicit recognition that the criteria are somewhat uncertain. So if there's any controversy whatsoever about the comparability of a new device to the predicate device, I think the inclination will be to just not do anything," Friede concludes.

- Jessica Bylander ( ⁴ j.bylander@elsevier.com )

FDA To Implement Recommendations From 510(k) Task Force Within Months

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