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Regulatory strategies to facilitate surgical innovation

      Phoebe Mounts, PhD, Esq, is a partner in the Food and Drug Administration Practice Group in the Washington, DC, office of Morgan Lewis & Bockius LLP. She counsels clients on regulatory issues for medical devices, drugs, and biologics. Prior to joining Morgan Lewis, she was on the faculty of the Johns Hopkins University School of Public Health in the Department of Molecular Microbiology, Immunology, and Infectious Diseases. Although she is a partner in the FDA Practice Group at Morgan Lewis, the views expressed in this article are hers and should not be attributed to the Firm.
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      References

      1. About the Center for Devices and Radiological Health. Available from: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/default.htm.

      2. Institute of Medicine. Medical devices and the public’s health: the FDA 510(k) clearance process at 35 years (2011). Available from: http://www.nationalacademies.org/hmd/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx.

      3. Public Citizen. Testimony encouraging a more rigorous approval process for medical devices. Available from: http://www.citizen.org/Page.aspx?pid=574.

      4. Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976).

      5. FDA. Learn if a medical device has been cleared by FDA for marketing. Available from: http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm.

      6. 21 C.F.R. § 807.92(a)(3).

      7. Section 515(c) of the FFDCA and 21 C.F.R. §814.20.

      8. Food and Drug Administration Modernization Act of 1997 (FDAMA), Public Law 105–115. 1997.

      9. Food and Drug Administration Safety and Innovation Act (FDASIA), Public Law 112–144. 2012.

      10. FDA guidance for industry, de novo classification process evaluation of automatic class III designation. 2014.

      11. FDA guidance for industry, requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff. 2014.

      12. FDA guidance for industry, expedited access for premarket approval and de novo medical devices intended for unmet medical need for life-threatening or irreversibly debilitating diseases or conditions. 2015.

      13. FDA. Celebrating a year of the expedited access pathway program for medical devices. Available from: http://blogs.fda.gov/fdavoice/index.php/2016/05/celebrating-a-year-of-the-expedited-access-pathway-program-for-medical-devices/.

      14. FDA guidance for industry, investigational device exemptions (IDEs) for early feasibility medical device clinical studies, including certain first in human (FIH) studies. 2013.