Medical Devices Regulatory Requirements

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 510 (k), unless exempt, or Premarket Approval …

Overview of Regulatory Requirements: Medical Devices

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

General controls require that all medical devices be properly labeled. Also, general controls require that all manufacturers, user facilities, and importers report when there's been an …

Regulatory Controls | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls

Classify Your Medical Device | FDA

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

For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical …

Quality and Compliance (Medical Devices) | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/quality-and-compliance-medical-devices

The FDA also recognizes that proper maintenance, repair, and servicing of medical devices is critical to maintaining the safe, effective, and reliable performance of devices used in …

Labeling - Regulatory Requirements for Medical Devices …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/labeling-regulatory-requirements-medical-devices-fda-89-4203

This publication explains label and labeling regulations and requirements for medical devices. The Food and Drug Administration has many labeling-related requirements to …

Quality System (QS) Regulation/Medical Device Good …

https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

Medical devices manufactured under an investigational device exemption (IDE) are not exempt from design control requirements under 21 CFR 820.30 of the QS …

Remanufacturing and Servicing Medical Devices | FDA

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

The FDA enforces requirements under the FD&C Act and its implementing regulations on entities engaged in remanufacturing, including but not limited to …

What Regulatory Requirements Does Your Medical …

https://www.mindflowdesign.com/insights/guide-medical-device-regulatory-requirements/

The FDA groups medical devices into three classes based on the device’s level of risk. Class I medical devices — such as bandaids and braces — carry the least amount of risk to patients and are therefore …

The Role of Regulatory Affairs in the Medical Device …

https://www.northeastern.edu/graduate/blog/regulatory-affairs-in-medical-device-industry/

If no predicate is available, regulatory affairs must submit a premarket approval application, or PMA, to demonstrate that the device is safe and effective for its intended uses. Regulatory affairs is also …