FDA initiative addresses streamlining, enhancing process of medical device pre-market submissions

By Lisa Kerner

Erie, Pa., May 22 - To keep pace with expected medical technology innovations and facilitate technology development over the next decade, the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) is undertaking a variety of initiatives and regulatory process improvements.

The CDRH's Medical Device Innovation Initiative is designed to promote scientific innovation in product development, focus device research on cutting edge science and modernizing review of innovative devices during the pre-market submission process, according to an FDA news release.

Much of the groundwork was laid for this initiative through The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which also provided resources for the device review process, the FDA said.

In 2006, the CDRH began a prioritization process for guidance document development to foster innovation while protecting public health.

The FDA said it plans to release guidance documents for innovative products, such as drug eluting stents, combination device/biologic products for cartilage repair, and genetic and pharmacogenomic tests.

Similar documentation will be issued related to innovative combination products and in vitro diagnostic devices.

Other CDHR initiatives include implementation of a quality review program for pre-market submissions, development of new IT systems that allow for better monitoring of pre-market submissions, piloting web-based software program for PMA reviews and expanding the use of outside experts.

The CDRH is also exploring the future development of integrated, searchable electronic databases to replace paper records and simplify the reviewers' task of retrieving information.

The FDA said that unlike pharmaceuticals, device innovation often includes giant leaps and incremental changes with life cycles as short as 18 months. Post-market systems that enable constant learning and feedback will encourage innovation and support best medical practices.

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