You are here：Home > news2017

FDA Registration -FAQs for Medical Device

Posted Date:2017/6/14

What is a medical device?

A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

· recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

· intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

· intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."  

Does FDA regulate medical devices?

Yes, FDA regulates a broad range of medical devices, including complicated, high-risk medical devices, like artificial hearts, and relatively simple, low-risk devices, like tongue depressors, as well as devices that fall somewhere in between, like sutures. FDA has authority to regulate medical devices before and after they reach the marketplace.

Do I need a prescription for a medical device?

Not all medical devices require a prescription; however, many medical devices do require a prescription (for example, contact lenses).

Who can write a prescription for a medical device?

Each state has laws and regulations that dictate who can write a prescription for a medical device in that state. FDA defers to the states on determining who can write a valid prescription.

What is the difference between FDA-listed, 510(k) exempt, cleared and approved medical devices?

FDA-listed medical devices: A medical device is FDA-listed if the firm that manufactures or distributes the medical device has successfully completed an online listing for the device through the FDA Unified Registration and Listing System (FURLS). (While manufacturers are the entities that typically list medical devices, they are not the only entities responsible for doing so.)

510(k) exempt medical devices: Medical devices that do not require FDA review before the devices are marketed are considered "510(k) exempt." These medical devices are mostly low-risk, Class I devices and some Class II devices that have been determined not to require a 510(k) (named for a section in the Food, Drug, and Cosmetic Act) to provide a reasonable assurance of safety and effectiveness.

These devices are exempt from complying with premarket notification requirements subject to the limitations on exemptions; however, they are not exempt from certain general controls. For example, 510(k) exempt devices must

· be suitable for their intended use

· be adequately packaged and properly labeled

· have establishment registration and device listing forms on file with FDA

· be manufactured under a quality system (with the exception of a small number of class I devices that are subject only to complaint files and general recordkeeping requirements)

Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to another legally marketed device. A premarket notification, referred to as a 510(k), must be submitted to FDA for clearance. A 510(k) is most often submitted by the medical device manufacturer.

Approved medical devices: Approved medical devices are those devices for which FDA has approved a premarket approval (PMA) application prior to marketing. This approval process is generally reserved for high-risk medical devices and involves a more rigorous premarket review than the 510(k) pathway.

Are medical devices regulated for non-medical reasons?

Yes, if the device is an electronic product that emits (or if unshielded, would emit) electronic product radiation. Manufacturers of such electronic products should be aware that certain radiation protection requirements and recommendations exist under 21 CFR Subchapter J - Radiological Health.

Medical devices are just a subset of electronic products that may have general regulatory provisions. Some electronic product manufacturers have specific performance, reporting, and recordkeeping standards that must be met before and after their electronic products enter into commerce. Examples of the types of electronic product radiations that are regulated include x-rays and other ionizing radiation, ultraviolet, visible, infrared, microwave, radio and low frequency radiation, coherent radiation produced by stimulated emission, and infrasonic, sonic, and ultrasonic vibrations.