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  • 21 CFR Part 814 -- Premarket Approval of Medical Devices
    § 814 9 Confidentiality of data and information in a premarket approval application (PMA) file (a) A “PMA file” includes all data and information submitted with or incorporated by reference in the PMA, any IDE incorporated into the PMA, any PMA supplement, any report under § 814 82, any master file, or any other related submission
  • PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
    Scope This section implements sections 515 and 515A of the act by providing procedures for the premarket approval of medical devices intended for human use References in this part to regu-latory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted
  • For patients without return of spontaneous circulation (ROSC), why am I . . .
    Per Ref 814, Determination Pronouncement of Death in the Field, the Base Physician must determine the decision for transport or termination for patients who do not meet criteria for termination of resuscitation in section II A
  • CFR - Code of Federal Regulations Title 21
    For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR) Page Last Updated: 12 24 2024 Note: If you need help accessing information in different
  • 21 C. F. R. PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
    (a) A “PMA file” includes all data and information submitted with or incorporated by reference in the PMA, any IDE incorporated into the PMA, any PMA supplement, any report under §814 82, any master file, or any other related submission
  • 21 CFR Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES
    LII Electronic Code of Federal Regulations (e-CFR) Title 21—Food and Drugs CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H—MEDICAL DEVICES PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES
  • [Code of Federal Regulations] [Title 21, Volume 8] DEVICES
    This section implements sections 515 and 515A of the act by providing procedures for the premarket approval of medical devices intended for human use References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted
  • Part 814—Premarket Approval of Medical Devices - eCFR. io
    Browse 21 CFR Part 814, Premarket Approval of Medical Devices current through 2026-06-05
  • Part 814 - Premarket Approval of Medical Devices
    § 814 44 - Procedures for review of a PMA § 814 45 - Denial of approval of a PMA § 814 46 - Withdrawal of approval of a PMA § 814 47 - Temporary suspension of approval of a PMA
  • Federal Register, Volume 91 Issue 108 (Friday, June 5, 2026)
    After receiving an order from FDA classifying the device into class III under section 513 (f) (1) of the FD C Act, the person then requests a classification under section 513 (f) (2)





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