How to Prepare a Traditional 510(k)

There are three types of Premarket Notification 510(k)s that may be submitted to the FDA:
Traditional (/medical-devices/premarket-notification-510k/how-prepare-traditional-510k),
Special (/medical-devices/premarket-notification-510k/how-prepare-special-510k), and
Abbreviated (/medical-devices/premarket-notification-510k/how-prepare-abbreviated-510k).
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
(/regulatory-information/search-fda-guidance-documents/special-510k-program) and The
Abbreviated 510(k) Program (/regulatory-information/search-fda-guidancedocuments/abbreviated-510k-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.
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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)]. (/regulatory-information/search-fda-guidancedocuments/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k)
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 (/medical-devices/premarket-notification510k/how-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)]. (/regulatory-information/search-fda-guidancedocuments/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k)
The FDA issues guidance documents to communicate the Agency’s recommendations to
industry. These documents are available through the Guidance Documents (/regulatoryinformation/search-fda-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 (/medicaldevices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-goodmanufacturing-practices) 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
(/regulatory-information/search-fda-guidance-documents/format-traditional-and-abbreviated510ks)” for the suggested format and content of a Traditional 510(k).
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For additional recommendations on content of a 510(k) submission , refer to the Content of a
510(k) (/medical-devices/premarket-notification-510k/content-510k) and 510(k) Format Tips
(/medical-devices/premarket-notification-510k/510k-format-tips) .
Where to Submit a 510(k)
A 510(k) submission must be submitted in an electronic format (eCopy) (/medical-devices/howstudy-and-market-your-device/ecopy-program-medical-device-submissions). 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 (/medical-devices/how-studyand-market-your-device/ecopy-program-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 (/medical-devices/premarket-notification510k/510k-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 (/medical-devices/premarket-submissions/medical-device-user-fees).
Resources
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification
510(k)
Format for Traditional and Abbreviated 510(k)s (/regulatory-information/search-fdaguidance-documents/format-traditional-and-abbreviated-510ks)
CDRH Learn Module: 510(k) Program
(http://fda.yorkcast.com/webcast/Play/d91af554691c4260b5eca0b2a28e636b1d) 
8/20/2020 How to Prepare a Traditional 510(k) | FDA
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(http://www.fda.gov/about-fda/website-policies/website-disclaimer)
510(k) Format Tips (/medical-devices/premarket-notification-510k/510k-format-tips)
Content of a 510(k) (/medical-devices/premarket-notification-510k/content-510k)

Sample Solution

ACED ESSAYS