Regulatory Pathway

FDA (Food and Drug Administration) is a federal agency of the United States Department of Health and Human Services, and also a federal executive department of the United States. The control and supervision is the responsibility of FDA for promoting public health and protecting of food safety, dietary supplements, vaccines, biopharmaceuticals, blood transfusions, medical devices, cosmetics, animal foods & feed and veterinary products. As FDA announces lot many plans that keep the safety and regulatory pathway in food and medical industry.

Amendments to the Federal Food Drug and Cosmetics Act in 1976 expanded the agency’s role to oversee safety in the development of medical devices. Medical Devices are regulated by the Centre for Devices and Radiological Health (CDRH) at the FDA. As Federal food, drug and cosmetic act are a set of laws and which gives authority to the US Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. According to the Federal Food Drug and Cosmetics Act, a device is “an instrument, apparatus, implement, machine, contrivance, implant or an in vitro reagent”.

So now, if a medical device manufacturer wants to get its product to market, the manufacturer has to determine the appropriate FDA classification of its medical device. As the medical device are classified whether your device fits into the Class I, Class II or Class III category. These medical devices are not classified based on your device design or the risk of the device but actually on “what your device will do” or “what your device is to be used for”.


Once the product (medical device) classification is done, now it’s time for premarket submission pathway, which is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. If your product is basically the same as a currently marketed medical device i.e. a predicate of your device, then you need to file a 510(k). Otherwise, if your device is Class III then the PMA process i.e. The Premarket Approval is the solution for you.

As discussed above the 510(k) i.e. pre-market notification and PMA i.e. premarket approval, are the two most common pathways for medical devices to market in the United States. And this both pathways are divided into three different types. For 510(k) it has subtypes that are the traditional, special and abbreviated forms and for the PMA it is traditional, modular and streamlined.

At the increasing efficiency of the 510(k) process, FDA intends to take several actions in the upcoming year that may create a great impact on the approval of the medical device pathway. FDA now plans and approves several guidance documents that are intended to create more detailed information regarding the FDA determinations.


Besides this FDA intends to streamline it’sde novoreview process, which is the fastest growing pathway for bringing unique, lower-risk medical devices to the market. The main point of de novo is that it is simpler than the 510(k) and is the risk mitigation strategy. This is particularly important for new devices that cannot point to clear comparable devices on the market but do not pose greater risks to safety. The de novo process involves a review of a device submission after the FDA has made the initial determination that the device is not substantially equivalent to any currently being marketed.

The FDA’s review of medical devices through the 510(k) or PMA process is complex. Operon Strategist has extensive experience successfully navigating medical devices through FDA review. For more information on FDA’s review of medical devices, please contact us at Operon Strategist.