Medical Device Notification

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Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

Submit reports to the FDA through the MedWatch program in one of the following ways: Complete the MedWatch Online Reporting Form. Download form or call 1-800-332-1088 to request a reporting form ...

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

CDRH 2022 Annual Report. Accomplishments for 2022, including the Pandemic Response, MDUFA V, Device Innovation, over-the-counter (OTC) hearing aid final rule, and device …

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

Device Advice. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling …

Medical Device Safety | FDA

https://www.fda.gov/medical-devices/medical-device-safety

Medical Device Safety. The FDA monitors reports of adverse events and other …

Medical Device Recall Information - Philips …

https://www.usa.philips.com/healthcare/e/sleep/communications/src-update

In June 2021, after discovering a potential health risk related to the foam in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips Respironics issued …

Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

Summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could …

Class I and Class II Device Exemptions | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions

Most class I and some class II devices are exempt from 510 (k) requirements, subject to certain limitations (see section 510 (l) (1) of the Federal Food, …

FDA notification rules for medical device supply chain protection

https://www.emergobyul.com/news/us-fda-rolls-out-notification-requirements-protect-medical-device-supply-chains

February 23, 2022. The US Food and Drug Administration has published new guidance on reporting and notification requirements to better mitigate supply …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal …