The following new items were added to the CDRH web pages on September 24, 2018. Previous CDRH New items can be found on the CDRH New webpage.
- Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics - Guidance for Industry and Food and Drug Administration Staff
- Webinar - Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Final Guidance - November 1, 2018
- November 15, 2018 - Patient Engagement Advisory Committee Meeting Announcement
- Meeting materials posted for September 27, 2018 Neurological Devices Panel of the Medical Devices Advisory Committee
- Mammography Problems at Aims Diagnostic Imaging in Manahawkin, NJ: FDA Safety Communication
- Collaborative Communities: Addressing Healthcare Challenges Together
- Federal Register: Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device
- Federal Register: Benefit-Risk Factors To Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics; Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Pediatric Medical Device Development; Public Meeting; Request for Comments; Reopening of Comment Period
.png)
No hay comentarios:
Publicar un comentario