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