To market a Class I, II, or III medical device intended for human use in the U.S., the device either requires a Premarket Approval Application (PMA) or a 510(K), unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions of the device classification regulation chapters.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective (“substantially equivalent”) to a legally marketed device that is not subject to a PMA. That is, submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims. (The legally marketed device(s) to which equivalence is drawn is commonly known as the “predicate” device.) Although the best practice is usually to select a predicate device which was recently cleared under 510(k), any legally marketed device may be used as a predicate. To be clear, a “legally marketed” predicate must be in compliance with the Act. Certain other requirements are placed on appropriate predicates, such as their date in commerce and other factors.
Unfortunately, there is no 510(k) form. However, The Law Office of Robert P. Mino, PA, help you navigate selection of a predicate and can advise on requirements for a 510(k) submission.
Before marketing the 510(K) medical device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent and states that the device can be marketed in the U.S. This order “clears” the device for commercial distribution. Until the submitter receives an order declaring a device substantially equivalent, the submitter may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S. If FDA determines that a device is not substantially equivalent, our office can advise on a few paths forward.
The substantially equivalence determination is usually made within 90 days and is made based on the information submitted by the submitter. A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.
FDA 510(k) Inspection
Although the facility will be required to file an establishment registration with the FDA, it is important to note that the FDA does not perform 510(k) pre-clearance facility inspections. Thus, the submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance. The submitter should already have an appropriate quality system in place prior to submitting their 510(k). If you need help creating a quality system, Robert P. Mino has led a team which has created a medical device quality management system from the ground up and can help provide guidance on support to get your quality system in place.
Third Party Review
In order to expedite the 510(k) review process, the FDA’ Center for Devices and Radiological Health (CDRH) has implemented a Third Party Review Program. This program provides an option to manufacturers of certain devices of submitting their 510(k) to private parties (Accredited Person) identified by FDA for review instead of submitting directly to CDRH. By law, FDA must issue a final determination within 30 days after receiving the recommendation of an Accredited Person.
Most Class I devices and a few Class II devices are exempt from the 510(k) premarket notification requirements, subject to limitations on exemptions, but are not exempt from other general controls. That is, all medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA. A few Class I devices are additionally exempt from the GMP requirements with the exception of complaint files and general record keeping requirements. Devices exempt from 510(k) are pre-amendment devices not significantly changed or modified (i.e. “grandfathered”) or Class I/II devices specifically exempted by regulation. There are nuances of this generalized description, which we can help clarify.
Requirements for Class I/II 510(k) Exempt Devices
Even though a 510(k) is not required, it is necessary to meet other requirements for marketing. These include:
- Registration and Listing