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104. Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff : guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719815-pdf

105. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719834-pdf

106. Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719840-pdf

109. Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff

nlm:nlmuid-101719884-pdf

112. Product labeling for certain ultrasonic surgical aspirator devices: guidance for Industry and Food and Drug Administration staff

nlm:nlmuid-101719888-pdf

113. Manufacturers sharing patient-specific information from medical devices with patients upon request: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719889-pdf

116. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment

nlm:nlmuid-101719919-pdf

117. Recurrent herpes labialis: developing drugs for treatment and prevention

nlm:nlmuid-101719926-pdf

119. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719954-pdf

120. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception

nlm:nlmuid-101719973-pdf

122. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

nlm:nlmuid-101719981-pdf

123. Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719987-pdf

124. Nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV): testing, product disposition, and donor deferral and reentry

nlm:nlmuid-101719989-pdf

125. FDA categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions: guidance for sponsors, clinical investigators, industry, institutional review boards, and Food and Drug Administration staff

nlm:nlmuid-101719990-pdf

126. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101720001-pdf

127. Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components

nlm:nlmuid-101720003-pdf

131. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system

nlm:nlmuid-101720038-pdf

133. Unique device identification: policy regarding compliance dates for class I and unclassified devices : immediately in effect guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101720053-pdf