Premarket Notification 510(k) - 21 CFR Part 807 Subpart E

21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S.

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, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.

A device is substantially equivalent if, in comparison to a predicate it:

• has the same intended use as the predicate; and
• has the same technological characteristics as the predicate;
or
• has the same intended use as the predicate; and
• has different technological characteristics and the information submitted to FDA;
• does not raise new questions of safety and effectiveness; and
• demonstrates that the device is at least as safe and effective as the legally marketed device.

A device may not be marketed in the U.S. until the submitter receives a letter declaring the device substantially equivalent. If FDA determines that a device is not substantially equivalent, the applicant may:

• resubmit another 510(k) with new data,
• request a Class I or II designation through the de novo process
• file a reclassification petition, or
• submit a premarket approval application (PMA).

When a 510(k) is Required?

A 510(k) is required when:

1. Introducing a device into commercial distribution (marketing) for the first time. After May 28, 1976 (effective date of the Medical Device Amendments to the Act), anyone who wants to sell a device in the U.S. is required to make a 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date.
2. You propose a different intended use for a device which you already have in commercial distribution. The 510(k) regulation (21 CFR 807 ) specifically requires a 510(k) submission for a major change or modification in intended use.
3. There is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness. The burden is on the 510(k) holder to decide whether or not a modification could significantly affect safety or effectiveness of the device. Any modifications must be made in accordance with the Quality System regulation, 21 CFR 820, and recorded in the device master record and change control records.

Subpart E--Premarket Notification Procedures

Summary of Requirements:

Sec. 807.81 When a premarket notification submission is required.
Sec. 807.85 Exemption from premarket notification.
Sec. 807.87 Information required in a premarket notification submission.
Sec. 807.90 Format of a premarket notification submission.
Sec. 807.92 Content and format of a 510(k) summary.
Sec. 807.93 Content and format of a 510(k) statement.
Sec. 807.94 Format of a class III certification.
Sec. 807.95 Confidentiality of information.
Sec. 807.97 Misbranding by reference to premarket notification.
Sec. 807.100 FDA action on a premarket notification.