The following new items were added to the CDRH web pages on March 29, 2019. Previous CDRH Newitems can be found on the CDRH New webpage.
- Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection - Guideline for Industry and Food and Drug Administration Staff
- Review and Update of Device Establishment Inspection Processes and Standards - Draft Guidance for Industry
- Presentations posted for March 25, 2019 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting
- Press Release: FDA finalizes requirements to help foster access to safe and effective tests to detect anthrax-causing bacteria
- Federal Register: Review and Update of Device Establishment Inspection Processes and Standards; Draft Guidance for Industry; Availability
- Federal Register: Orthopedic Devices; Classification of Posterior Cervical Screw Systems
- Federal Register: Medical Devices; Technical Amendment
- Federal Register: Microbiology Devices: Classification of In Vitro Diagnostic Devices for Bacillus Species Detection
- Federal Register: Radiological Health Regulations: Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser and Ultrasonic Products
.png)
No hay comentarios:
Publicar un comentario