CDRH’s Regulatory Science Priorities
Posts published in “United States Food and Drug Administration – US FDA”
Medical Device User Fee Rates for Fiscal Year 2020
Updated FDA Resources for Third Party Review Organizations
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment
Postmarketing Safety Reporting for Combination Products
Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions
FDA Recognizes AAMI Standard and TIR
The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from…
Digital Health Update: Mid-Year Update on Software Precertification Program
Programmable CSF Shunts and Magnetic Field Interference with Implanted Hearing Devices – Letter to Health Care Providers