FDA issues for comment a draft guidance to aid industry in designing and executing appropriate performance testing for three types of guidewires.
Federal Register notice: FDA classifies brain trauma assessment tests into Class 2 (special controls).
Federal Register notice: FDA classifies the endoscopic electrosurgical clip cutting system into Class 2 (special controls).
Federal Register notice: FDA makes available a draft guidance entitled Patient-Focused Drug Development: Collecting Comprehensive and Representative I...
Federal Register notice: FDA makes available a draft guidance entitled Humanitarian Device Exemption (HDE) Program.
CBER says it will use secure e-mail for regulatory communications with sponsors as of 10/1.
FDA clears a LivaNova 510(k) for its MEMO 4D semi-rigid mitral annuloplasty ring.
FDA clears an Optovue 510(k) for its Avanti Widefield Optical Coherence Tomography system for non-contact, quantitative measurements of the epithelial...