Minnetronix - Medical Device Design & Manufacturing

  1. The Ever-Changing Regulatory Environment

    by Steve Strong, VP of Quality & Regulatory Affairs August 2011: Vital Signs Minnetronix Newsletter


    The FDA’s Center for Devices and Radiological Health (CDRH), under the direction of Dr. Jeffrey Shuren, is actively working to address recent industry and political concerns regarding the 510(k) device approval process. These concerns include the unpredictability of the 510(k) process and the resulting negative impact on the medical device industry, as well as the bearing the process has on making innovative devices available to patients. These concerns have been expressed while at the same time criticism has recently arisen regarding the agency’s inadequacy in addressing their charter of protecting patient safety.

    To address these concerns, the CDRH initiated two highly visible activities focused on the 510(k) device approval process as a result of an internal review and input from industry experts and the public. The first initiative was a release of a 25-item action plan for improving the 510(k) process in August of 2010. The second was a request to the Institute of Medicine (IOM) to conduct an independent review of the 510(k) process in order to provide recommendations for improvement.

    The resulting IOM report was released on July 29, 2011, and its final conclusion was to replace the 510(k) process with an integrated premarket and post-market regulatory framework. Unfortunately, the IOM recommendation did not provide details or specifics on how the framework should appear.

     Immediately following the release of the IOM report, Dr. Shuren said, “The FDA believes that the 510(k) process should not be eliminated, but we are open to additional proposals and approaches for continued improvement of our device review programs.” CDRH is currently reviewing the details of the report and is soliciting input from industry and the public regarding the report.

    In addition to these initiatives the CDRH is actively working on releasing guidance documents that provide industry direction as well as convey CDRH’s current thinking. As a reference point, in the last six months there have been 13 guidance documents and 13 draft guidance documents released for public comment. Of these 26 documents, there are seven which are not device-specific and therefore have a broader industry impact:

    1. Draft Guidance: Post Market Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act: (8/16/11)

    2. Draft Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices: (8/15/11)

    3. Draft Guidance: Risk Determinations in Medical Device Premarket Review: (8/15/11)

    4. Guidance for Industry and FDA Staff: 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device: (7/27/11)

    5. Draft Guidance: Mobile Medical Applications: (7/21/11)

    6. Draft Guidance: Applying Human Factors and Usability Engineering to Optimize Medical Device Design (6/22/11)

    7. Guidance for Industry and FDA Staff: 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: (4/13/11)

    While we at Minnetronix track all highly visible FDA activities, we are careful to pay particular attention to the guidance and draft guidance documents because these have a more immediate impact on our customers as well as the medical device as a whole. We will continue to review documents as they are released and provide information to our customers regarding possible impacts on internal processes or to any development and manufacturing projects. If you have questions regarding regulatory environment activities, please contact me at (651) 917-4060 or sstrong@minnetronix.com.