Industry, analysts react to 510(k) reform ideas

Members of the medical device industry have had generally positive reactions to the proposed changes to the 510(k) program announced Wednesday. Many controversial issues were deferred until a later date, leaving Derrick Sung, an analyst at Sanford C. Bernstein, to say the announcement "amounted to a non-event as decisions and/or details around the most controversial proposals were delayed," Bloomberg reports.

As MassDevice notes, the medical industry has been successful in cobbling together bipartisan support in its fight against radical changes to the program. Fifteen senators and 12 House members wrote to Margaret Hamburg last year, urging caution with regards to the proposed changes. Signers of the letter included Rep. Joseph Pitts (R-PA), now chairman of the Health subcommittee of the House E&C Committee.

Furthermore, adds MassDevice, industry allies are in other key House positions. For example, Brett Loper left a job as AdvaMed's lead lobbyist to join House Speaker John Boehner's (R-OH) staff as policy director.

The FDA's list of 25 actions does propose the creation of a new Center Science Council to help standardize the review process and streamlined processes for lower-risk devices. And according to CDRH Director Jeffrey Shuren, the FDA's actions will create "a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe and effective technologies to patients quickly."

"I wouldn't say we've won. I wouldn't say that," Medtronic CEO Bill Hawkins told MassDevice. "I would say that we're working towards a more collaborative and constructive working relationship with the FDA, recognizing that we both have the same common goals to advance innovation that is safe and effective. I think this, in my judgement, is a good sign coming out to the FDA."

The non-profit California Healthcare Institute also expressed some enthusiasm for the initial recommendations. CHI was happy the agency acknowledged there are a number of controversial recommendations "such as the creation of a new category of devices known as Class IIb and restrictions on predicates, and that the agency has requested further review by the Institutes of Medicine."

Not everyone was pleased with today's announcement, however.

"FDA has backed down on important safety measures that would have saved lives," said Diana Zuckerman, president of the National Research Center for Women & Families, as quoted by Reuters.  The center has acknowleged that it appreciates innovation, but warned, "Patients can be harmed if innovation results in products that are less safe and less effective than older products that are already available and often less expensive," the group said last year in comments last year on the FDA's proposal to strengthen the 510(k) review process.

There is still some unease in the industry, despite the delay on controversial issues. "The controversial items are still to be determined. So it's a smaller cloud hanging over the industry, but it's still a cloud. There's still uncertainty," says Piper Jaffray analyst Thomas Gunderson, as quoted by Reuters.

- see the FDA's rules
- read the CHI release
- get more from MassDevice's interview with Bill Hawkins
- and see its Capitol Hill report
- see more from Bloomberg
- read the Reuters report

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