reimbursement@wiki

Food and Drug Administration

Drugs

 

Devices

• 501(k)

• • Search 510(k) Database

  • Search Classification Database

  • Search Device Listing Database

• Premarket Approval (PMA)

• • Overview

• Humanitarian Device Exemption (HDE)

• • Guidance for Industry and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers (July 18, 2006)

• ARTICLES

• • (attached) Medical Device Regulation - An Introduction for the Practicing Physician (2004)

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