Subjects: Device Approval and United States - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Device Approval ✖ Subjects United States ✖

71. Enforcement policy for clinical electronic thermometers: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 3, 2023
Subject(s):: Device Approval
Government Regulation
Guideline Adherence
Thermometers -- standards
United States

72. Enforcement policy for certain supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 2, 2023
Subject(s):: Compassionate Use Trials
Device Approval
Government Regulation
Guideline Adherence
United States

73. Notifying FDA of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, November 17, 2023
Subject(s):: Correspondence as Topic
Device Approval
Government Regulation
Manufacturing Industry
United States
United States.

74. Assessing the credibility of computational modeling and simulation in medical device submissions: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 17, 2023
Subject(s):: Computer Simulation
Device Approval
Government Regulation
United States

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