Used Medical Equipment Regulations

Overview of Device Regulation | FDA

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

The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing,...

Remanufacturing and Servicing Medical Devices | FDA

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

Reprocessing of Reusable Medical Devices | FDA

https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices

Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients. Examples of reusable medical devices include …

Overview of Regulatory Requirements: Medical Devices

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

This slide gives some examples of the products we regulate at the Center for Devices and Radiological Health: anything from MRI equipment, to stethoscopes, adhesive …

Durable Medical Equipment (DME) Center | CMS

https://www.cms.gov/Center/Provider-Type/Durable-Medical-Equipment-DME-Center

The Centers for Medicare & Medicaid Services (CMS) recently issued a final rule that takes effect on February 28, 2022 and classifies non-implantable continuous glucose monitors …

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

• The equipment is a medical laser device; or • New equipment without a sufficient amount of maintenance history has been acquired. • Hospitals electing to adjust …

Safety of Metals and Other Materials Used in Medical …

https://www.fda.gov/medical-devices/products-and-medical-procedures/safety-metals-and-other-materials-used-medical-devices

As part of premarket submissions, medical device manufacturers submit information such as an evaluation of biocompatibility, to the FDA to demonstrate that the …

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, …

Transporting contaminated surgical instruments for …

https://www.osha.gov/laws-regs/standardinterpretations/2013-01-31-2

1910.1030 (d) (2) (viii) 1910.1030 (d) (4) (ii) OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements …

Exception to the rule: shipping used medical devices

https://www.medicaldevice-developments.com/features/featureexception-to-the-rule-regulations-for-shipping-used-medical-devices/

On 1 January 2013 the international regulatory bodies that oversee the air transport of infectious and biological substances worldwide published a new exception to the …