FDA
The Food and Drug Administration of the US has published the final guidance on the Pilot Accreditation Scheme for Conformity Assessment Program. The document constitutes a final version of the guidance initially issued earlier in September 2019. Due to its legal...
FDA
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices and other healthcare products, announced the new improvements and amendments to the Software Precertification Pilot Program. FDA Pre-Cert Pilot Program in Brief...
FDA
The Food and Drug Administration (FDA) has announced new improvements to the electronic Medical Device Reporting (eMDR) system to simplify uploading data and storing information related to adverse events associated with medical devices. The amended rules would be also...
FDA
The Food and Drug Administration (FDA) has published detailed guidance dedicated to the use of International Standard ISO 10993-1 “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”. International...
FDA
The Food and Drugs Administration (FDA), the US authority responsible for medical device regulation, has published a guidance document dedicated to the annual reports for Pre-market Approval Applications (PMA) that have been approved. Regulatory Background According...
FDA
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, allows the manufacturers to use national and international voluntary consensus standards when preparing and evaluating premarket submissions for medical devices. ...
