NLM Digital Collections

Search

Search Constraints

Start Over You searched for: Subjects United States Remove constraint Subjects: United States Languages English Remove constraint Languages: English

Search Results

8024. 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

8025. 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

8028. E2B(R3) electronic transmission of Individual Case Safety Reports (ICSRs) implementation guide: data elements and message specification

8029. Technical performance assessment of quantitative imaging in radiological device premarket submissions: guidance for industry and Food and Drug Administration staff

8030. Electromagnetic compatibility (EMC) of medical devices: guidance for industry and Food and Drug Administration staff