FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to balancing premarket and postmarket data collection for medical devices subject to premarket approval....
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a final guidance document dedicated to the submission of 510(k) notifications for changes to medical devices that have already been...
FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to providing regulatory submissions for medical devices in the electronic format under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Submissions in...
FDA
The Food and Drug Administration (FDA) issued select updates for guidance relating to animal studies for the non-clinical and clinical investigation of medical devices used for the treatment of benign prostatic hyperplasia (BHP). Regulatory Background and Scope of the...
FDA
The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, issued guidance on supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions in the context of the outbreak of the...
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.
Get the report
