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  6. Premarket Notification 510(k)
  7. 510(k) Submission Programs
  1. Premarket Submissions

510(k) Submission Programs


Overview

A submitter may choose from three types of Premarket Notification 510(k) submissions to seek marketing clearance for their device when appropriate for review under the 510(k) Program: Traditional, Special, and Abbreviated.

The Traditional Program is the original submission type as provided in 21 CFR 807. In 1998, the FDA developed both the Special and Abbreviated 510(k) Programs to facilitate the review of certain types of submissions subject to 510(k) requirements. These Programs were previously described in The New 510(k) Paradigm guidance.  In 2019, the FDA split "The New 510(k) Paradigm" guidance into two distinct guidance documents: The Special 510(k) Program and The Abbreviated 510(k) Program. The Special 510(k) and Abbreviated 510(k) submission types can be used when a 510(k) submission meets certain factors.

The use of either alternative Program does not affect the FDA's ability to obtain any information authorized by the statute or regulations necessary to make a determination regarding whether the device is or is not substantially equivalent to a predicate device.

Some device changes may be implemented without submission of a new 510(k). The submitter should review the  Is a new 510(k) required for a modification to the device? webpage to determine whether a new 510(k) is required for the change to the device.

The user fee is the same for Traditional, Special, and Abbreviated 510(k)s. See Medical Device User Fees for additional information.


Traditional 510(k)

The Traditional 510(k) may be used for any original 510(k) or for a change to a previously cleared device under 510(k).

Subject to the FDA's acceptance review in accordance with the guidance Refuse to Accept Policy for 510(k)s, the FDA generally reviews Traditional 510(k) submissions within 90 days of receipt. For more information about the different FDA and industry actions taken on 510(k)s and the effect each action has on Medical Device User Fee Agreement (MDUFA) performance goals, see the guidance FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals.

See How to Prepare a Traditional 510(k) for additional information on Traditional 510(k)s.


Special 510(k)

Device manufacturers may choose to submit a Special 510(k) for changes to their  own existing device if the method(s) to evaluate the change(s) are well-established, and when the results can be sufficiently reviewed in a summary or risk analysis format. A Special 510(k) would generally not be appropriate for devices that manufacture a biological product at the point of care, because there would likely be no well-established method to evaluate such changes and/or the performance data would not be reviewable in a summary or risk analysis format.  

As identified in the guidance The Special 510(k) Program, design or labeling change(s) to an existing device (including certain changes to the indications for use) may be appropriate for a Special 510(k) when:

  1. The proposed change is submitted by the manufacturer legally authorized to market the existing device;
  2. Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change; and
  3. All performance data necessary to support substantial equivalence can be reviewed in a summary or risk analysis format.

Subject to the FDA's acceptance review in accordance with the guidance Refuse to Accept Policy for 510(k)s, the FDA generally reviews Special 510(k) submissions within 30 days of receipt as discussed in the guidance The Special 510(k) Program.

See How to Prepare a Special 510(k) for additional information on Special 510(k)s.


Abbreviated 510(k)

Device manufacturers may choose to submit an Abbreviated 510(k) when the submission relies on:

  • FDA guidance document(s),
  • Demonstration of compliance with special control(s) for the device type, or
  • Voluntary consensus standard(s).

An Abbreviated 510(k) submission must include the required elements identified in 21 CFR 807.87 [Traditional 510(k)]. However, in an Abbreviated 510(k) submission, firms elect to provide summary reports on the use of guidance documents and/or special controls or declarations of conformity to the FDA's recognized standards to facilitate the review of a submission. Manufacturers submitting an Abbreviated 510(k) that relies on general use of a voluntary consensus standard should include the basis of such use along with the underlying information or data that supports how the standard was used.

Subject to the FDA's acceptance review in accordance with the guidance Refuse to Accept Policy for 510(k)s, the FDA generally reviews Abbreviated 510(k) submissions within 90 days of receipt. For more information, see the guidance The Abbreviated 510(k) Program.

See How to Prepare an Abbreviated 510(k) for additional information on Abbreviated 510(k)s.


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