FDA Medical Device Regulation Guide 2022: How the Courts and the FDA Interpret and Enforce the Law - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "FDA Medical Device Regulation" directory has been added to ResearchAndMarkets.com's offering.

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.

Key Topics Covered:

• Overview of FDA Device Regulation
• FDA Jurisdiction Over Devices
• Registration, Listing, and Labeling Requirements
• Classification and Reclassification
• Investigational Device Exemption - IDE
• Quality Systems
• Premarket Approval - PMA
• Premarket Notification - 510(k)
• Reporting and Tracking Requirements
• Exports and Imports
• Enforcement
• FDA Device Regulation's Relationship with Other Federal Authorities
• State Regulations and Preemption

For more information about this directory visit https://www.researchandmarkets.com/r/w8avep

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