FDA Medical Device Regulatory Guide 2022: How Courts and FDA Interpret and Apply the Law – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “FDA Medical Device Regulation” directory has been added to from ResearchAndMarkets.com offer.

The Guide to Medical Device Regulation contains the highest quality analysis of medical device regulation – including how the courts and the FDA interpret and apply the law – and practical advice to help you take informed action. and efficient.

The Guide keeps you up to date with the latest, complete and concise information that is important to you and your business.

In one convenient source, this guide includes device coverage and reimbursement information from the Centers for Medicare and Medicaid Services.

Main topics covered:

  • Overview of FDA Device Regulations

  • FDA jurisdiction over devices

  • Registration, listing and labeling requirements

  • Classification and reclassification

  • Investigational Device Exemption – IDE

  • Quality Systems

  • Pre-market approval – PMA

  • Premarket Notification – 510(k)

  • Reporting and Tracking Requirements

  • Exports and imports

  • Enforcement

  • Relationship Between FDA Device Regulation and Other Federal Authorities

  • State regulations and preemption

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

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