Non Prescription Medical Devices

Over-the-Counter (OTC) Medical Devices: …

https://www.fda.gov/medical-devices/products-and-medical-procedures/over-counter-otc-medical-devices-considerations-device-manufacturers

Over-the-Counter (OTC) Medical Devices: Considerations for Device Manufacturers Over-the-counter (OTC) medical devices are those that may be offered for sale directly to the consumer. In...

Best over-the-counter hearing aids of 2023

https://www.medicalnewstoday.com/articles/non-prescription-hearing-aids

A quick look at 5 of the best nonprescription hearing aids Best for a budget: Walmart Go Prime Best for battery options: Audicus …

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 …

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

Over-the-Counter (OTC) Hearing Aids | NIDCD

https://www.nidcd.nih.gov/health/over-counter-hearing-aids

Personal sound amplification products (PSAPs) are another class of amplifying devices that you can purchase without a prescription or seeing a health care …

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 …

Over-The-Counter (Non-Prescription) Medical Devices

https://www.fda.gov/medical-devices/general-device-labeling-requirements/labeling-requirements-over-counter-non-prescription-medical-devices

Labeling Requirements - Over-The-Counter (Non-Prescription) Medical Devices | FDA Labeling Requirements - Over-The-Counter (Non-Prescription) Medical Devices …

General Device Labeling Requirements | FDA

https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-requirements

Labeling Requirements - Over-The-Counter (Non-Prescription) Medical Devices Labeling Requirements - Exemptions From Adequate Directions For Use Labeling Requirements - …

Medical Device Regulation for non-medical products

https://www.medicaldevice-network.com/sponsored/medical-device-regulation-non-medical-products/

Medical Device Regulation for non-medical products - Medical Device Network Partner Content May 10, 2021 Medical Device Regulation for non-medical …

Devices without a medical purpose - BIOREG services

https://bioregservices.com/blog/devices-without-a-medical-purpose/

Take, as an example, non-corrective contact lenses (commonly known as plano lenses) or decorative lenses which are not considered to be medical devices under the Medical Device Directive …