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 dedicated to the main principles of software validation. The document is intended to assist medical device...
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 Unique Device Identifiers. Apart from other aspects, the guidance covers the matters related to...
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 describing De Novo Classification Requests in the context of the effect on the FDA review clock and goals. The...
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 the Global Unique Device Identification Database (GUDID). The document is intended to provide...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to the regulatory requirements for hearing aid devices and personal sound amplification products....
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 postmarket management of cybersecurity in medical devices. The document is intended to provide...
