Recently Posted Guidance Documents on Devices, Administrative / Procedural, Radiology Devices, Premarket

Devices

11/29/2017  Recommendations for Dual 510(k) and CLIA Waiver by Application Studies - Draft Guidance for Industry and Food and Drug Administration Staff

11/29/2017 Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff

Radiology Devices, Premarket

11/28/2017  Pediatric Information for X-ray Imaging Device Premarket Notifications - Guidance for Industry and Food and Drug Administration Staff

Administrative / Procedural

11/27/2017  Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier