The following new items were added to the CDRH web pages on April 13, 2018. Previous CDRH Newitems can be found on the CDRH New webpage.
- Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices - Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing-Based In Vitro Diagnostics Intended To Aid in the Diagnosis of Suspected Germline Diseases; Guidance for Stakeholders and Food and Drug Administration Staff; Availability
- Use of Public Human Genetic Variant Databases To Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics; Guidance for Stakeholders and Food and Drug Administration Staff; Availability