21 CFR Part 807, Subpart B - Procedures for Device Establishments

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There are 2 Updates appearing in the Federal Register for 21 CFR Part 807. View below or at eCFR (GPOAccess)

Title 21 published on 2015-04-01.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2016-10-12; vol. 81 # 197 - Wednesday, October 12, 2016
    1. 81 FR 70339 - Medical Devices; Custom Devices; Technical Amendment
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective October 12, 2016.
      21 CFR Parts 807 and 812

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 807 after this date.

  • 2016-10-17; vol. 81 # 200 - Monday, October 17, 2016
    1. 81 FR 71415 - Electronic Submission of Labeling for Certain Home-Use Medical Devices
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit either electronic or written comments on the proposed rule by January 17, 2017. In accordance with 21 CFR 10.40(c), in finalizing this rulemaking FDA will review and consider all comments submitted before the time for comment on this proposed regulation has expired. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by November 16, 2016; see section VI, the “Information Collection Requirements” section of this document. See section VIII of this document for the proposed effective date of a final rule based on this proposed rule.
      21 CFR Part 807