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  7. How to Prepare a Traditional 510(k)
  1. Premarket Notification 510(k)

How to Prepare a Traditional 510(k)


Overview

There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and Abbreviated. 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 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 Traditional 510(k) Program can be used under any circumstance to seek marketing authorization of a device through the 510(k) Program.

There is no Premarket Notification 510(k) "form" to complete. A 510(k) is a submission containing information required under 21 CFR 807.87. All 510(k)s are based on the concept of substantial equivalence (SE) to a legally marketed device, also referred to as a predicate. All 510(k)s provide a comparison between the device to be marketed and the predicate device or devices.

For more information on the regulatory framework, policies, and practices underlying the FDA's 510(k) review, please refer to the guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)].


Find a Predicate Device

You should identify a primary predicate device which is most similar to the device you intend on submitting through the 510(k) Program with respect to indications for use and technological characteristics. Under certain circumstances, you may claim SE to more than one predicate. We recommend the 510(k) number of the predicate device(s) be identified. Please refer to How to Find and Effectively Use Predicate Devices for additional guidance.


Locate Guidance Documents

For more information on the regulatory framework, policies, and practices underlying the FDA's 510(k) review process, please refer to the guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)].

The FDA issues guidance documents to communicate the Agency's recommendations to industry. These documents are available through the Guidance Documents page.

Device-specific guidance documents may describe in detail the information for inclusion in the 510(k) submission to facilitate the FDA's review for that particular type of device. We recommend that device-specific guidance documents be consulted at the device planning stage. In addition, the design control requirements (21 CFR 820.30) of the Quality System regulation should be reviewed as well.


Content and Format of a Traditional 510(k)

In addition to the items required under 21 CFR 807.87 and 21 807.90, CDRH suggests that you refer to the FDA guidance document entitled, "Format for Traditional and Abbreviated 510(k)s" for the suggested format and content of a Traditional 510(k).

For additional recommendations on content of a 510(k) submission , refer to the Content of a 510(k) and 510(k) Format Tips .


Where to Submit a 510(k)

A 510(k) submission must be submitted in an electronic format (eCopy). Once a 510(k) submission is received by the FDA, we do NOT return the submission or any copies to the submitter. You should retain a copy of your 510(k) for your records. Your medical device submission package should be sent to CDRH's or CBER's Document Control Center (DCC). The current mailing address for CDRH's DCC and a link to CBER's DCC's mailing address are provided on the eCopy Program for Medical Device Submissions webpage.

We recommend that you send your 510(k) to the FDA by a method that will provide a signed receipt of delivery, e.g., registered mail with a return receipt or a commercial delivery service. You should receive an acknowledgment of receipt from the FDA that includes the assigned 510(k) number. The 510(k) Submission Process webpage describes the review process after the submission is received by the FDA.


User Fees for a Traditional 510(k)

Traditional, Special, and Abbreviated 510(k)s require the same user fee. Do NOT send the fee with the submission. Information on how to submit the user fee can be found at Medical Device User Fees.


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