FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published detailed guidance dedicated to design control. The document was issued by the Center for Devices and Radiological Health (CDRH) earlier in...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a discussion paper dedicated to strengthening cybersecurity practices associated with servicing medical...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the unique device identification system. In particular, the document is...
FDA
The Food and Drug Authority (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the regulatory procedures related to requests for information as prescribed by Section 513(g) of the Federal...
FDA
The core principles of the regulatory approach for labeling for medical devices are described in a guidance document issued by the Food and Drug Administration (FDA or the Agency), the US regulating authority, earlier in 1989. Since that time, the document has been...
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 medical device reporting requirements for manufacturers. The document provides an overview of the key...
