FDA and Japanese regulators recently began to work together to review two devices - one U.S.-manufactured, one Japanese-made - that are part of a new pilot program intended to model how products can achieve faster market entry in both countries.

The two selected devices are superficial femoral artery stents, but the regulatory agencies are not naming the sponsoring companies in order to protect confidential and trade secret information, according to FDA reviewer Erica Takai, who works in the cardiovascular device evaluation division.

"We gave consideration among the projects that were submitted in terms of public health benefits as well as the novelty of the devices and we also wanted to balance the selection process between Japan and the U.S.," Takai said in a March 3 interview.

Takai provided an update on the cardiovascular device pilot program, which was first announced in June ¹ Also see "U.S.-Japan Pilot Project In Pre-Market Collaboration Begins Soon" - Medtech Insight, 26 October, 2009.), at the CRT 2010 conference in Washington, D.C., on Feb. 23. She noted that there are no approved femoral artery stents in Japan and "not many" in the U.S., so the selection of these devices on Oct. 27 "served a public health benefit."

Bard's LifeStent and W.L. Gore's Viabahn are the only two femoral artery stents on the U.S. market, but several companies, including ev3, Abbott, Cook Medical and Johnson & Johnson are conducting trials for bare-metal and/or drug-eluting stents for the indication (² Also see "Bard’s LifeStent Gets Legs: PMA Approved For Femoral, Popliteal Arteries" - Medtech Insight, 23 February, 2009.).

"We didn't intend to choose two projects from any particular device area, but it just so happened that these two SFA stent projects that we chose were best suited based on the criteria from our June announcement and also, we did give some consideration in terms of the project's ability to show some kind of tangible process within the year," Takai explained.

Pilot Include More Back-And-Forth With Sponsors

Part of what makes the collaborative review pilot program unique is the regular contact with the product sponsors throughout the process, explained Carole Carey, director of Director of International Staff at CDRH, in an interview.

"We already have a communication confidentiality arrangement with [Japan's Ministry of Health, Labor and Welfare and its Pharmaceuticals and Medical Devices Agency], in which we can actually share information, but that's just between the regulators," she pointed out.

Takai noted that a three-way interaction with one of the selected sponsors has already been scheduled "within the next several months."

In addition, FDA and Japanese reviewers are in contact on a monthly basis.

CDRH staff most recently met with Japanese device reviewers Feb. 24 at the agency's White Oak, Md., facility, Carey said.

The collaborative reviews of the two chosen femoral artery stents will likely run through the completion of the review of each device, she said.

Other Firms Get Taste Of Collaborative Approach

Also, the U.S. and Japanese regulators are offering a one-time collaborative interaction to the seven companies who had submitted devices for entry consideration to the pilot, but were ultimately not chosen, Takai said.

"We envision that this interaction could be a three-way telecon, or the communication could be via e-mail, whatever we see as appropriate and most fitting," she explained. "I think that will be case-by-case."

The projects included cardiovascular devices other than SFA stents, she added.

FDA welcomes feedback from industry members "in terms of how they might wish to use this program, or any comments from a sort-of logistical standpoint," Takai noted. She pointed out that although the pilot was limited to cardiovascular devices, manufacturers of other types of products are welcome to comment, too.

"Eventually, the hope is that once we lay the groundwork for this program ... it can be expanded to other areas, so I think we like to be open and have an open ear to industry's suggestions," she said.

- Ingrid Mezo ( ³ i.mezo@elsevier.com )

U.S., Japan Regulators Begin Collaborative Review Pilot With Femoral Stents

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