MEDICAL AND FOOD

Medical device recalls include voluntary recalls covered by 21 CFR part 7 subpart C either initiat… Read more Fda Recall Guidance Medical Device

Medical devices legislation The adoption in April 2017 of Regulation EU 2017745 on Medical Devices… Read more Fda Medical Device Regulation And Guidance

As a part of our surveillance of medical devices on the market the FDA monitors reports of cyberse… Read more Fda Medical Device Cybersecurity Guidance

Guidance document implant card on the application of Article 18 Regulation EU 2017745 on medical d… Read more Fda Medical Device Guidance Documents

Neither FDA nor ISO 13485 provide much instruction on medical device process validation and instea… Read more Fda Process Validation Guidance Medical Devices

Center for Devices and Radiological Health FDA is issuing this guidance to clarify how we evaluate… Read more Fda Guidance Documents Medical Devices