LegalFix
Individuals & FamiliesSmall BusinessesEmployersEmployee Benefits BrokersPEOsCredit UnionsMembership GroupsLegal Information
Sign In
  1. /
  2. U.S. Code of Federal Regula...
  3. /
  4. Title 21-Food and Drugs
  5. /
  6. CHAPTER I—FOOD AND DRUG ADM...
  7. /
  8. PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES


PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES


  • § 814.1 - Scope.
  • § 814.2 - Purpose.
  • § 814.3 - Definitions.
  • § 814.9 - Confidentiality of data and information in a premarket approval application (PMA) file.
  • § 814.15 - Research conducted outside the United States.
  • § 814.17 - Service of orders.
  • § 814.19 - Product development protocol (PDP).
  • § 814.20 - Application.
  • § 814.37 - PMA amendments and resubmitted PMAs.
  • § 814.39 - PMA supplements.
  • § 814.40 - Time frames for reviewing a PMA.
  • § 814.42 - Filing a PMA.
  • § 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.
  • § 814.80 - General.
  • § 814.82 - Postapproval requirements.
  • § 814.84 - Reports.
  • § 814.100 - Purpose and scope.
  • § 814.102 - Designation of HUD status.
  • § 814.104 - Original applications.
  • § 814.106 - HDE amendments and resubmitted HDE's.
  • § 814.108 - Supplemental applications.
  • § 814.110 - New indications for use.
  • § 814.112 - Filing an HDE.
  • § 814.114 - Timeframes for reviewing an HDE.
  • § 814.116 - Procedures for review of an HDE.
  • § 814.118 - Denial of approval or withdrawal of approval of an HDE.
  • § 814.120 - Temporary suspension of approval of an HDE.
  • § 814.122 - Confidentiality of data and information.
  • § 814.124 - Institutional Review Board requirements.
  • § 814.126 - Postapproval requirements and reports.
We have updated our Terms of Service, Privacy Policy, and Disclosures. By continuing to browse this site, you agree to our Terms of Service, Privacy Policy, and Disclosures.
AboutContact UsPrivacyTermsDisclosuresAccessibilitySite Map

Copyright ©2024 LegalFix. All rights reserved. LegalFix is not a law firm, is not licensed to practice law, and does not provide legal advice, services, or representation. The information on this website is an overview of the legal plans you can purchase—or that may be provided by your employer as an employee benefit or by your credit union or other membership group as a membership benefit.

LegalFix provides its members with easy access to affordable legal services through a network of independent provider law firms. LegalFix, its corporate entity, and its officers, directors, employees, agents, and contractors do not provide legal advice, services, or representation—directly or indirectly.

The articles and information on the site are not legal advice and should not be relied upon—they are for information purposes only. You should become a LegalFix member to get legal services from one of our provider law firms.

You should not disclose confidential or potentially incriminating information to LegalFix—you should only communicate such information to your provider law firm.

The benefits and legal services described in the LegalFix legal plans are not always available in all states or with all plans. See the legal plan Benefit Overview and the more comprehensive legal plan contract during checkout for coverage details in your state.

Use of this website, the purchase of legal plans, and access to the LegalFix network of provider law firms are subject to the LegalFix Terms of Service and Privacy Policy.

Bookish