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Start Over Collections Health Policy and Services Research ✖Remove constraint Collections: Health Policy and Services Research Copyright Public domain ✖Remove constraint Copyright: Public domain Publication Year 2022 ✖Remove constraint Publication Year: <span class="single" data-blrl-single="2022">2022</span>

221. Orthopedic fracture fixation plates: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, April 11, 2022
Subject(s):
Device Approval
Equipment Safety
Fracture Fixation
Orthopedic Fixation Devices -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

229. 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

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 2022
Subject(s):
Compassionate Use Trials -- legislation & jurisprudence
COVID-19
Device Approval -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

230. 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

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 6, 2022
Subject(s):
Clinical Studies as Topic
Diabetes Mellitus, Type 2 -- drug therapy
Glycemic Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration