Industry Called Upon to Submit Proposed Improvements to Medical Device Review Process

When it comes to the review of medical devices, how do you think the US Food and Drug Administration (FDA) is doing? While the question is usually left to be answered in the opinion pages of trade publications, the passage of the Medical Device User Fee Act (MDUFA)-part of the FDA Safety and Innovation Act-has opened up a public opportunity for medical device manufacturers to comment on the agency's review processes.

The assessment, called for under Section V of the MDUFA commitment letter, is intended to bring together regulators and industry for a "comprehensive assessment of the process for the review of device applications."

That process has frequently been under fire in recent years from members of industry, who have at times claimed that the process is too slow and inconsistent relative to the EU's medical device regulatory clearance process. The joint review hopes to improve FDA's Center for Devices and Radiological Health (CDRH) by approaching the improvement process using the same set of facts and figures.

The two-stage assessment process is being conducted by a "private, independent consulting firm," and its findings are set to be published in waves, with high-priority items published by the end of 2013, and all results by the middle of 2014. The second phase, the implementation of the report's recommendations, will occur by 1 February 2016.

For now, though, FDA's notice calls for industry to send forth its view on ways CDRH can make improvements and implement best practices to its device review process, including the review of 510(k) premarket notifications, premarket approval (PMA) applications, pre-submissions and investigational device exemptions (IDEs). Also sought are industry's views on how FDA collects, controls and reports information on its performance metrics, whether FDA is effective enough at training its staff, and the need for any focused assessments of FDA programs.

Eventually, the recommendations reached by the assessment process will be incorporated into a Good Review Management Practices (GRMP) guidance document, but likely not until 2016.

Comments on the assessment process are due to FDA within 30 days of its publication in the Federal Register, expected to occur on 20 December 2012. Comments then would be due by 19 January 2013.