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A Quick Guide to the Basics of the FDA’s Purpose and Process

The FDA is responsible for a number of areas that help to protect public health, including the assurance that foods are properly labelled, sanitary, wholesome and safe. They will also protect people from electronic product radiation, will ensure dietary and cosmetic supplements are correctly labelled, will regulate tobacco products and will assist in speeding up product innovations.

A Quick Guide to the Basics of the FDA's Purpose and Process

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In order to regulate these, the FDA has a number of different processes in place. Here are just some of the ones involved in regulating medical devices.

FDA-Listed Medical Devices

To have a medical device successfully FDA-listed, organisations will need to seek this by completing an online listing via the FDA Unified Registration and Listing System (FURLS). It isn’t just manufacturers who are responsible for doing this, despite them being the ones that typically do so.

510(K) Exempt Medical Devices

A “510(k) exempt” medical device is one that’s deemed not to require an FDA review prior to being marketed. The majority of these will be Class I devices, seen as being low-risk, while some Class II devices will also be determined as not requiring a 510(k).

Even though these devices do not have to comply with the requirements laid out, they won’t be exempt from a number of basic controls. They must be manufactured under a quality system (some class I devices will be exempt from this as they are subject to general record-keeping requirements or complaint files), be registered as an establishment and have listing forms on file with the FDA, be properly labelled and packaged, and be suited for their intended use.

Cleared Medical Devices

These types of medical devices are ones that are seen to be substantially equivalent to another device that has been legally marketed. To register this, a premarket notification
will need submitting, which is known as a 510(k). For an FDA 510k clearance submission, organisations can do this in a number of ways, including through companies such as http://www.fdathirdpartyreview.com/. These will normally be submitted by the manufacturer of the medical device.

Approved Medical Devices

Medical devices that fall under this category are ones that have been given premarket approval by the FDA. This will have been granted prior to the product being marketed and this normally involves a rigorous approval process and one that is reserved for high-risk medical devices.


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