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FDA Memo Hints at Curbs to Approval Process for Medical Devices

http://online.wsj.com/article/SB10001424052748704398804575071791464778482.html?mod=googlenews_wsj

FEBRUARY 17, 2010, 7:12 P.M. ET
By ALICIA MUNDY And JARED A. FAVOLE

WASHINGTON—The Food and Drug Administration may tighten or eliminate several pathways for getting a medical device approved quickly amid concerns they have been overused by industry, according to an internal agency memo reviewed by The Wall Street Journal.

The proposals came in a Dec. 22 briefing involving officials in the FDA's device division.

According to the memo, officials questioned the increasing use of private companies that are hired by device makers to pre-review products. If the third party signs off on the device, the FDA may approve it without much further scrutiny. The memo notes the "Real value to industry may be that this is perceived as a way to 'sneak things in."'

Jeffrey Shuren, head of the FDA's device division, said in a statement that the Dec. 22 meeting discussed "initial findings" about possible changes.

The industry will have a chance to air its views at a public meeting Thursday. Dr. Shuren declined to discuss specific moves the FDA might make, saying he doesn't want to influence the meeting "by emphasizing any particular point that has been part of very preliminary staff discussions."

The FDA began a review of device approvals last fall after stories in The Wall Street Journal about a knee implant called Menaflex. The ReGen Biologics Inc. device was approved in late 2008 using a fast-track process called 510(k) over the objections of a half-dozen FDA scientists and managers during a four-year battle. The 510(k) process is designed for products that are similar to earlier devices, known as predicate devices.

The FDA report on the Menaflex decision noted that the 510(k) process was subject to abuse because in some cases the link between the new product and earlier devices was tenuous. More than 3,000 devices get approved through 510(k) annually.

Device company executives and industry analysts have said they expect regulations to tighten this year. The industry says the FDA shouldn't erect excessive barriers to innovative products. It says the 510(k) process is an effective way to get devices to patients quickly.

Analysts at Washington Analysis said in a research note, "The changes (to 510k) will undoubtedly increase the cost of device development, a clear advantage for larger companies."

In its memo, the FDA questioned how much leverage the agency has under existing law to demand more data from companies that use the 510(k) process.The notes say, "How do we deal with predicate devices after we decide to raise the bar?" and add that current regulations pose "challenges" for the FDA.

FDA officials said one option is to eliminate a program known as special 510(k), in which device makers can declare that their new device conforms to an earlier one they make except for a specific modification. This lets them get approval decisions within 30 days. The officials also discussed keeping the program while tightening the rules. The memo noted that roughly a quarter of all 510(k) approvals go through the specials program.

The memo noted that FDA reviewers often can't check the veracity of summaries made by companies in real time, and said that there had been at least one rescission of a special 510(k) device "based on false information."

The memo says the FDA also has concerns about abuses in its third-party review program. It says third-party reviewers often lack expertise and "often just repeat what is in the submission" from the device company without analyzing it. As a possible solution, the memo says the FDA may limit devices eligible for third-party reviews.

In fiscal year 2008, the FDA received 301 devices through the third-party program, up from 185 in 2003, according to its annual report.

In the memo, FDA officials acknowledge that there is confusion within the division about what approval standards to apply, and sometimes inconsistency in what is demanded of companies and how their products are judged. The industry has often complained that the FDA sends mixed signals about regulations to device makers.

The FDA's 510(k) working group has scheduled a briefing for device division employees on Feb. 24.

Write to Alicia Mundy at [e-mail] and Jared A. Favole at [e-mail].