Medical Equipment Regulation

Overview of Device Regulation | FDA

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

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are: Establishment registration, Medical Device Listing, Premarket Notification...

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the …

An Introduction to FDA’s Regulation of Medical Devices

https://www.fda.gov/media/123602/download

Medical Device, defined Instrument, apparatus, machine, implant, in vitro reagent, including component, part, or accessory Diagnoses, cures, mitigates, treats, or prevents disease or …

Remanufacturing and Servicing Medical Devices | FDA

https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/remanufacturing-and-servicing-medical-devices

Overview of Regulatory Requirements: Medical Devices

https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript

If it's one of those two, the FDA would regulate that product as a drug. This slide gives some examples of the products we regulate at the Center for Devices and Radiological …

Medical devices - World Health Organization

https://www.who.int/health-topics/medical-devices

A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other …

Hospital Equipment Maintenance Requirements | CMS

https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Survey-and-Cert-Letter-14-07

• Hospitals electing to adjust facility or medical equipment maintenance must develop policies and procedures and maintain documentation supporting their …

Medicare Durable Medical Equipment, Prosthetics, …

https://www.cms.gov/newsroom/fact-sheets/medicare-durable-medical-equipment-prosthetics-orthotics-and-supplies-dmepos-final-rule-cms-1738-f

On December 21, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that furthers the agency’s commitment to strengthen Medicare …

DMEPOS Federal Regulations and Notices | CMS

https://www.cms.gov/medicare/durable-medical-equipment-prostheticsorthotics-and-supplies-fee-schedule/dmepos-federal-regulations-and-notices

CMS-1738-F, CMS-1687-F, and CMS-5531-F: Medicare Program; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues, and …

Medical devices | European Medicines Agency

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

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …