Synopsis
Medical Device Development: Regulation and Law, 2020 Edition, is the must-have practical reference for regulatory affairs professionals. This authoritative text provides the most comprehensive and updated analysis of U.S. medical device and diagnostics development and approval requirements anywhere. The new edition offers analysis of new FDA device regulations, including all new significant guidance documents, and addresses how emerging developments and trends are reshaping medical device and combination product regulations in the United States. * Update on the new medical device provisions of the 21st Century Cures Act and the Food and Drug Administration Reauthorization Act of 2017. * New statutory provisions and guidance documents related to regulation of software as a medical device, cybersecurity, general wellness products, real-world evidence, use of benefit risk information for both premarket and post-market processes, and when post-clearance changes require submission of a new 510(k) notice. * Update on the new TPLC organizational structure of CDRH. * Updates to the pre-submission process, including new MDUFA IV goals for meetings and feedback. * Updates to FDA's refusal to accept and review policies relating to 510(k)s, PMAs, and pre-submissions. * Update on the investigational device exemption process including new guidance documents and policies related to clinical trials, including IDE benefit-risk considerations, new Good Clinical Practices (GCPs) guidance and policy for use of foreign data, policies regarding ClinicalTrials.gov registration, as well as guidance documents on adaptive design, leveraging data for pediatric use, and demographic factors in clinical studies. * Changes to the premarket approval application process including FDA guidance on distinguishing between 30-Day Notice PMA Supplements and Site Change PMA Supplements. * New policies and guidance documents concerning in vitro diagnostic products, including updates on research and investigational use and laboratory developed tests. * Update on device compliance issues, including the 2016 medical device reporting guidance. * New guidance documents and cases relating to combination products incorporating medical devices. * New changes to FDA's review of requests for issuance of certificates to foreign governments. * FDA policy regarding the regulation of third party reprocessors.
About the Author
Jonathan S. Kahan, Partner, Hogan Lovells US LLP is based in Washington, D.C. Jon is a co-director of the firm's food, drug, medical device, and agriculture group, and has been practicing in FDA law for 40 years. Jon is also an Adjunct Professor at the George Washington University Law School teaching medical device law. His practice focuses primarily on assisting medical device companies in navigating the U.S. Food and Drug Administration (FDA) regulatory process. He also has an extensive practice in combination products, which includes combinations of drugs, devices, and biologics. In addition to the daily counseling of clients in FDA-related matters, he represents many clients in administrative hearings and trials, and in the federal courts. Jon has published numerous law review and other articles concerning FDA regulatory issues. Michael S. Heyl served as a co-author and lead editor for this book. Mike helps medical device companies through U.S. Food and Drug Administration (FDA) regulations, requirements, and compliance issues. These issues include FDA's Quality System Regulation (QSR); adverse event reporting; recall reporting requirements; FDA inspections and enforcement actions, such as Warning Letters; defense strategies; and corrective and remedial action plans. He represents large multinational corporations facing FDA and criminal enforcement, and helps small start-ups develop and implement post-market compliance programs. Because he understands FDA's requirements for importing and exporting medical devices, Mike is frequently called on to negotiate the release of detained goods being imported to the U.S. Mike also works with device companies in conducting regulatory due diligence and negotiating corporate mergers and acquisitions and initial public offerings. He has been involved with numerous transactions ranging from multi-billion dollar acquisitions to the negotiation of supply and distribution agreements.
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