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Frequently Asked Questions About Home Use Devices
- https://www.fda.gov/medical-devices/home-use-devices/frequently-asked-questions-about-home-use-devices
- Not all medical devices require a prescription; however, many medical devices do require a prescription (for example, contact lenses). Q: How can I find out if my medical device...
Overview of Regulatory Requirements: Medical Devices
- https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript
- FDA has classified all medical devices into either Class I, II, and III. Currently, in the Code of Federal Regulations, there are about 1700 devices that have been classified by the …
What the FDA considers a Prescription Device
- https://elsmar.com/elsmarqualityforum/threads/what-the-fda-considers-a-prescription-device-decisions-and-implications.66417/
- Decision: How do you decide if your device is prescription or not? Does the FDA have any guidance, or is it purely up to the manufacturer and their stated intended …
Colored and Decorative Contact Lenses: A Prescription …
- https://www.fda.gov/consumers/consumer-updates/colored-and-decorative-contact-lenses-prescription-must
- Internet sites that do not require a prescription These are not authorized distributors of contact lenses, which are prescription devices by federal law. In addition, …
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