CDRH New

December 30, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on December 29, 2020. To view listings for other dates, see CDRH New - News and Updates.

• Product Labeling for Laparoscopic Power Morcellators - Guidance for Industry and Food and Drug Administration Staff
• UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication
• Laparoscopic Power Morcellators (Updated)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190035 and DEN200016 added)
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 6, 2021
• COVID-19 Tests and Collection Kits Authorized by the FDA in 2020: Infographic
• Center for Devices and Radiological Health's Response to Coronavirus (COVID-19): Infographic (Updated)
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
• Federal Register: Requests for Nominations: Technical Electronic Product Radiation Safety Standards Committee; Voting Members
• Federal Register: Guidance: Product Labeling for Laparoscopic Power Morcellators