FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document providing recommendations on the content and format of non-clinical bench performance testing information in the...
FDA
The Food and Drug Administration (FDA) has published a discussion paper dedicate to the cybersecurity vulnerabilities associated with medical devices. In particular, the document describes the best practices to be considered when communicating with the healthcare...
FDA
The Food and Drug Administration (FDA), the US regulating authority, has published guidance describing technical considerations for non-clinical assessment of medical devices containing nitinol. The present document constitutes a final version of the draft guidance...
FDA
The Food and Drug Administration (FDA) has published draft guidance on updates for biocompatibility of certain devices in contact with intact skin. Notes The public consultations period commenced on October 15, 2020, and would last for 60 days during which the...
FDA
The Food and Drug Administration (FDA) has published a guidance document providing standards specific information on biocompatibility testing of the medical device in the context of the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. Regulatory...
