Enhancing Safety and Efficiency
FDA Proposes Modifications to Medical Device User Fee Small Business Qualification and Certification
FDA Makes Changes to Device GMPs to Align More Closely with International Consensus Standards.
FDA’s 2023 device registration renewal period!
FDA’s Regulation of OTC Hearing Aids vs. PSAPs Last fall, FDA released its final rule establishing a regulatory category for Over-the-Counter (OTC) hearing aids, pursuant
Over the years, FDA has issued a number of Import Alerts across various FDA product categories.