Medical Device Companies Need From The FDA: Clarity, Predictability & Transparency."

Medical Device Companies Need From The FDA: Clarity, Predictability & Transparency."

US FDA’s CDRH which is responsible for approval of medical devices in the US is informally teaming up with  San Diego-based life sciences trade group to see if they can get medical devices reviewed more quickly, so they can safely reach the market sooner.

Biocom is working informally with the U.S. Food and Drug Administration to redesign the medical device approval process to eliminate cumbersome and unnecessary steps, said Joe Panetta, Biocom's president and CEO, and Jeffrey Shuren, who heads the FDA's Center for Devices and Radiological Health in Silver Spring, Md. They spoke about the project with reporters Tuesday

So engagement of trade groups in the US could be a step forward to reduce the burden on the FDA.

As for all businesses, medical device makers equate time with money. Delays in getting a product approved for marketing means delays in sales revenue. And in the fast-changing medical device field, delays increase the risk that the product will be rendered obsolete by a competitor

Medical devices don't have the cachet of the more glamorous biotech industry, (which Biocom also represents). But these devices also have advanced the quality of medical care, and created major industries and employment bases. Such devices include cardiac stents to keep open vital arteries, (manufactured locally by Abbott Vascular in Temecula, MDT in CA, BSCI in Boston, J&J), spinal implants (made by Carlsbad-based Alphatec Spine, Spine innovators like Spinofix, Inc based in Irvine) and ultrasound diagnostic tools (made by Carmel Valley-based Volcano Corp.).

FDA Keeping up a challenge

The FDA finds it challenging to deal with these new technologies and staff turnover has been an obstacle to efficient review, Panetta said. When a reviewer is replaced in the middle of a product evaluation, the whole timetable is set back until the new FDA staffer gets up to speed.

In three words, Panetta said, the medical device industry wants, "clarity, predictability and transparency."

Shuren said he agrees with those concerns and will try to meet them. In addition, he said he's sympathetic to complaints that  medical device makers are being asked to give information that's not really required for the FDA to do its job.

Instead of asking questions about things that are "nice to know," Shuren said, the FDA should limit its inquiries to matters that reviewers "need to know," to make sure products are safe and effective.

Shuren said the FDA sent representatives across the country in 2010 to listen to these concerns. The FDA also listened to those who said they weren't getting enough information about the "benefit-risk" profile of medical devices so that doctors and patients could make informed decisions.