Washington Wrap-Up: Shuren Says CDRH Will Do Better Job Communicating With Industry

CDRH is planning to issue early notice-to-industry letters as soon as device reviewers decide there has been a “change in expectations” on what is necessary for a device to receive approval or clearance, according to center director Jeffrey Shuren.

“In some cases, we do ask for things that we haven’t asked for before that are appropriate, and there are cases where we can do a better job communicating that beforehand,” Shuren told a House subcommittee on Oversight and Government Reform in June. “I will tell you that this occurs about less than 10% of the time where we ask for additional, but appropriate, information.”

Shuren told the lawmakers that a recent analysis found a number of instances where “agency reviewers asked for additional information based on a question we did not need to ask. This has occurred in less than 10% of 510(k)s and that is concerning to us. We are already putting in place changes in the program to address that, because we don’t want to see that happen.”

Shuren was asked to comment on industry complaints about the difficult and lengthy process of getting devices to market.
He said he has repeatedly heard from industry that more interactions with CDRH reviewers are needed. He added that “we agree.”

One challenge, he said, is that requests for meetings before submissions and before clinical trials have almost doubled during the past five years. Industry has requested “more opportunities for more engagement with the center during the review,” he said at the hearing.

Additionally, Shuren said poor-quality submissions are contributing to delays with approvals and clearances. A recent CDRH analysis of additional information letters sent in 2010 found that 50% of 510(k)s had submission quality concerns.

Rep. Erik Paulsen (R-MN), who co-chairs the House Medical Technology Caucus, testified during the hearing that “devices are approved two years earlier in Europe than in the U.S., denying our patients access to life-saving technology.”

He warned that “if this trend continues, more companies will look for greener pastures, and take their innovations and their 400,000 high-paying jobs with them.” Paulsen said he is working on legislation to make the device approval and clearance process more transparent.

“The FDA has a statutory mandate to consider the ‘least burdensome’ means of demonstrating devices meet safety and efficacy standards,” Paulsen told the subcommittee. “Unfortunately, in recent years the agency has abandoned this principle. The least burdensome provisions should force the agency to find an appropriate balance between patient protection and the development of new, life-saving products.”

Shuren told the subcommittee that FDA’s standard for medical device approval “is the robust standard we should stand behind.”

91% of QSR Warnings Cite Corrective or Protective Actions

CDRH says it issued 89 warning letters last year for violations of quality systems (QS) and good manufacturing practice regulations. In 81 of these (91%), the offending firm was cited for is corrective and preventive action (CAPA) activities, or a lack thereof, according to recent statistics. Sixty-nine letters contained citations for production and process controls, 49 letters cited design controls, and 43 cited management oversight. 

The center says the most frequent QS citations in the letters involved complaint-handling (42 letters). The next most popular citation was for failing to establish and maintain procedures for implementing CAPA (30 letters). And rounding out the top three: citations for process validation (28 letters).

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