Category: United States Food and Drug Administration – US FDA
FDA approves first contact lens indicated to slow the progression of nearsightedness in children
FDA clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection
Devices used for the condition of temporomandibular disorders (TMD), including temporomandibular joint (TMJ) implants.
Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices
Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid
Modifications to the List of Recognized Standards, Recognition List Number: 052
Breast Implants – Certain Labeling Recommendations to Improve Patient Communication
Color Hazard and RISk calculator (CHRIS) is being developed and validated under the MDDT framework.
CDRH Proposed Guidances for Fiscal Year 2020 (FY 2020)
Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling