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General Controls for Medical Devices | FDA
- https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices
- General Controls are the basic provisions (authorities) of the May 28, 1976 Medical Device Amendments (hereafter referred to as the Amendments) to the Food, Drug and Cosmetic Act, that provide the FDA with the means of regulating devices to ensure their safety and effectiveness. The General Controls in … See more
Classify Your Medical Device | FDA
- https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
- The three classes and the requirements which apply to them are: Device Class and Regulatory Controls 1. Class I General Controls With Exemptions Without Exemptions …
Overview of Regulatory Requirements: Medical Devices
- https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript
- It basically says a medical device is “any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate, diagnose disease in man”. Some …
Exporting Medical Devices | FDA
- https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/exporting-medical-devices
- The Center for Devices and Radiological Health (CDRH) is responsible for issuing export certificates for medical devices. To obtain an export certificate, a request must be …
Shop Controls - McKesson Medical-Surgical
- https://mms.mckesson.com/catalog?node=2179
- Shop Controls - McKesson Medical-Surgical Shop Medical Supplies & Equipment Clinical Laboratory Controls Shop Controls All Products ( 3,748) (0) Options Sort By Best Match …
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