Feb 7, 2023
FDA
The new article addresses the aspects related to the application of wireless technologies that are widely used in medical devices nowadays, as well as to certain safety-related matters. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
Read More
Feb 7, 2023
FDA
The new article covers the aspects related to usability testing to be conducted, and also to electrical safety and electromagnetic compatibility. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
Read More
Feb 2, 2023
FDA
The new article highlights the aspects related to reprocessing of photobiomodulation devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance...
Read More
Oct 22, 2020
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The Food and Drug Administration (FDA) has published draft guidance on updates for biocompatibility of certain devices in contact with intact skin.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...
Read More
Oct 13, 2020
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...
Read More