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  7. How to Prepare an Abbreviated 510(k)
  1. Premarket Notification 510(k)

How to Prepare an Abbreviated 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.


When to choose an Abbreviated 510(k)

The Abbreviated 510(k) relies on the use of guidance documents, special controls, and voluntary consensus standards. An Abbreviated 510(k) submission must include the required elements identified in 21 CFR 807.87 (Information required in a premarket notification submission). Under certain conditions, you may not need to submit test data in an 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 controls for the device type, or
  • voluntary consensus standard(s).

In an Abbreviated 510(k) submission, manufacturers provide summary reports based on the use of guidance documents and/or special controls, or declarations of conformity to recognized standards, to facilitate the FDA's review of a submission.

If the FDA determines that an Abbreviated 510(k) is not appropriate for review as submitted, the FDA will notify the submitter of this decision and convert the 510(k) to a Traditional 510(k). If the 510(k) is converted, the original receipt date remains as the start of the review period. Manufacturers should be aware that, in most cases, additional information will be necessary for converted documents.

Guidance Documents

For more information on the regulatory framework, policies, and practices underlying the FDA's 510(k) review for Abbreviated 510(k)s, please refer to the guidance The Abbreviated 510(k) Program.

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. An Abbreviated 510(k) that relies on a guidance document should include a summary report that describes how the guidance document was used to demonstrate substantial equivalence. The summary report should include information regarding the manufacturer's efforts to use the guidance document and should outline any deviations.

Special Controls

Special controls are a means of providing reasonable assurance of the safety and effectiveness for a Class II device. Special controls are defined in section 513(a)(1)(B) of the Federal Food, Drug, & Cosmetic Act (Act) as those controls, such as performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data), recommendations and other appropriate actions that provide reasonable assurance of the device's safety and effectiveness. The device's classification regulation lists special controls for the device, if any. Device classification regulations are located in 21 Code of Federal Regulations (CFR) part 862 through 892 and can also be found through the searchable product classification database.

An Abbreviated 510(k) that relies on special control(s) should include a summary report that describes adherence to the special control(s) and how the device complies with the special control(s), including how the special control(s) were used to address a specific risk or issue. The summary report should include information regarding the manufacturer's efforts to comply with the special control(s) and should outline any deviations.

Voluntary Consensus Standards

In addition to guidance documents and special controls, CDRH is committed to recognizing individual consensus standards. The FDA is authorized to recognize all or part of national and international standards. Recognized standards could be cited in guidance documents or preambles of regulatory documents such as a rule or order that describe specific risks associated with a type of device.

Guidance on the recognition and use of consensus standards can be found on CDRH's Standards and Conformity Assessment Program website.

Manufacturers submitting an Abbreviated 510(k) that relies on a voluntary consensus standard(s) should provide the information described in Appendix A of The Abbreviated 510(k) Program and a declaration of conformity as recommended by the guidance document Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. As noted in our guidance, 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.


Content and Format of an Abbreviated 510(k)

In addition to the items required under 21 CFR 807.87 and 21 807.90, CDRH recommends that you refer to the FDA guidance documents entitled, Format for Traditional and Abbreviated 510(k)s and The Abbreviated 510(k) Program for the suggested format and content of an Abbreviated 510(k).

For additional information on 510(k) submissions, see 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 an Abbreviated 510(k)

Traditional, Special, and Abbreviated 510(k)s require the same 510(k) 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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