Thompson FDA

Guide to Medical Device Regulation

Speed your new device to market and ensure that you understand your postmarket obligations.

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$822.00 Guide to Medical Device Regulation (Online)

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$959.00 Guide to Medical Device Regulation (Print)

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$1239.00 Guide to Medical Device Regulation (Online + Print)

Thompson's Guide to Medical Device Regulation contains the highest quality analyses on the regulation of medical devices — including how the courts and the FDA interpret and enforce the law — and practical guidance to help you take informed, efficient action. The Guide keeps you up-to-speed with the most current, comprehensive and concise information that is important to you and your business. In one convenient source, this guide includes information about Centers for Medicare and Medicaid Services device coverage and reimbursement.

Major Topics Covered

The Guide to Medical Device Regulation is an in-depth analysis of the FDA's requirements for medical devices — a practical guide that will aid you in making informed and efficient decisions by giving you information on the most up-to-date regulatory developments.

It will help you stay in compliance by providing useable, accurate, timely and comprehensive information on federal statutes, regulations and guidance governing the FDA’s approval, investigation, monitoring and enforcement activities related to devices commercially distributed in or exported from the United States.

In the two-volume Guide to Medical Device Regulation, you’ll find analysis of relevant laws, regulations, guidance and court rulings. Plus, your annual subscription includes updates and newsletters during the 12-month subscription period.

The Guide will keep you up-to-speed on all the recent regulatory developments such as:

  • Changes to the 510(k) program
  • New requirements imposed under the latest medical device user fee statute
  • FDA review times for PMAs and 510(k)s
  • The FDA’s unique device identifier requirements
  • Amendments to facility registration and device listing rules
  • Agency requirements for electronic copies of device submissions and electronic Medical Device Reporting
  • The reclassification of preamendment devices
  • The latest facility inspection and Warning Letter trends
  • The FDA’s newest postmarket surveillance tools and techniques
  • International standards and regulations governing medical devices
  • And much more….

Order today – not knowing is not a defense!

Summary of Contents

100 Overview of FDA Device Regulation
200 FDA Jurisdiction Over Devices
300 Registration, Listing, and Labeling Requirements
400 Classification and Reclassification
500 Investigational Device Exemption–IDE
600 Quality Systems
700 Premarket Approval – PMA
800 Premarket Notification – 510(k)
900 Reporting and Tracking Requirements
1000 Exports and Imports
1100 Enforcement
1200 FDA Device Regulation’s Relationship with Other Federal Authorities
1300 State Regulation and Prevention
Appendixes
Glossary
Indexes


About Your Subscription

You will receive either the two-volume Guide to Medical Device Regulation in print and/or access to the manual online at fda.complianceexpert.com. Based on the delivery method you choose, your annual subscription also includes monthly print and/or rolling digital updates, news, analysis and more at no additional charge for the 12-month subscription period. Additionally, online subscribers receive access to our FDA Enforcement Letter Database. If you have any questions or would like information about bulk pricing or site licenses, please contact Client Services at 800-677-3789 or by emailing service@thompson.com.


Authors and Editors

Mark A. Heller

Mark A. Heller is a partner with Goodwin Procter L.L.P., in Washington, D.C., where he chairs the firm's Food and Drug Administration practice group. Before entering private practice, Mr. Heller was associate chief counsel for medical devices at the FDA from 1984 to 1991. He also was an associate chief counsel for enforcement at the FDA (1981-1984) and a senior trial attorney for the Food and Drug Division at the Federal Trade Commission (1973-1981). He received his undergraduate degree with honors and his J.D. from the University of Wisconsin at Madison. For his work at the FDA and the FTC he received several awards for excellence. Mr. Heller played a significant role in developing the Safe Medical Devices Act of 1990 and represented device industry clients as legislative counsel in obtaining passage of the FDA Modernization Act of 1997. Mr. Heller also assisted the Advanced Medical Technology Association in obtaining further amendment of the Federal Food, Drug and Cosmetic Act's device provisions through the Medical Device User Fee and Modernization Act of 2002 and subsequent amendments. He is in a particularly experienced position from which to analyze the law and draw out the significance of regulatory activities to the medical device industry. Mark A. Heller is author and editor-in-chief of Guide to Medical Device Regulation.

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