NLM Digital Collections

Search

Search Constraints

Start Over You searched for: Subjects United States. Department of Health and Human Services Remove constraint Subjects: United States. Department of Health and Human Services Subjects United States. Food and Drug Administration Remove constraint Subjects: United States. Food and Drug Administration

Search Results

112. Supplements for approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions during the Coronavirus Disease 2019 (COVID-19) public health emergency (revised): guidance for Industry and Food and Drug Administration staff

113. Feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus: guidance for industry and Food and Drug Administration staff

116. E2B(R3) electronic transmission of Individual Case Safety Reports (ICSRs) implementation guide: data elements and message specification

117. Technical performance assessment of quantitative imaging in radiological device premarket submissions: guidance for industry and Food and Drug Administration staff