Medical Device Development: Regulation and Law, 2014 Edition, is the ''must-have'' resource for the novice or veteran medical device regulatory affairs professional. This practical reference provides the most comprehensive and updated analysis of US medical device and diagnostics development and approval requirements anywhere. Since the 2009 edition of this book, new device legislation has been enacted and FDA has issued over a dozen or more important new guidances. The 2014 edition features in-depth analysis of these developments, and addresses how emerging developments and trends are reshaping medical device and combination product regulations in the US. The 2014 edition of this popular and authoritative resource reviews and analyzes the following critical developments since the 2009 edition: * Update on all the new provisions of the Food and Drug Administration Safety and Improvement Act of 2012 (FDASIA). * New statutory provisions and guidances related to device reclassification, humanitarian devices, the CDRH appeal process, Section 522 postmarket surveillance, and custom devices. * New statutory provisions and guidances related to mobile medical apps and medical device software, including medical data software systems. * Updates on the new organizational structure of CDRH, including revisions to the structure of the Office of Device Evaluation the Office of Compliance, and the Office of In Vitro Diagnostics and Radiological Health. * Changes to the 510(k) premarket notification process, including new policies on split predicates, when a device cannot be found to be SE, and the new priority review guidance. * Changes to the pre-submission process, including the end of the pre-IDE process and the birth of the Q-sub. * New guidances on FDA s Refusal to Accept policies relating to 510(k)s, PMA s, and pre-submissions. * Update on the investigational device exemption process, including new guidances on early feasibility studies, FDA decisions for IDE investigations, design considerations for pivotal clinical device investigations, and good laboratory practices. * Changes to the premarket approval application process, including birth of the e-copy and modifications to the advisory panel process. * New policies and guidances concerning in vitro diagnostic products, including the new guidances on Research Use Only (RUO)/Investigational Use Only (IUO) products, and in vitro companion diagnostics. * Update on device compliance issues, including the 2013 draft medical device reporting guidance and recall procedures relating to product enhancements. * New guidances and cases relating to combination products incorporating medical devices.

Medical Device Development: Regulation and Law

Jonathan S. Kahan

Hogan Lovells US LLP

Reference

Parexel Intl Corp

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.

Michael S. Heyl

The 2015 edition of FDLI's signature reference work, Food and Drug Law and Regulation is the only comprehensive resource covering the field of food and drug law. For practicing attorneys, regulatory and compliance professionals, and others who need to understand the complex regulatory framework created by FDA and related agencies, including court decisions, legislation, enforcement actions, and international issues.

Food and Drug Law and Regulation, Third Edition

David G. Adams

Richard M. Cooper

Martin J. Hahn

Administrative Law

Food and Drug Law Institute

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Books by Jonathan S. Kahan