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  7. How To Prepare A Special 510(k)
  1. Premarket Notification 510(k)

How To Prepare A Special 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 Special 510(k) Program is intended to facilitate the submission, review, and clearance of a change to a manufacturer's own legally marketed predicate device ("existing device") that is already authorized for commercial distribution through 510(k) clearance, preamendments status, reclassification, or through a granted De Novo classification request under section 513(f)(2) of the FD&C Act. Refer to "Documentation Required for Preamendments Status" for the procedures for demonstrating preamendments status. Submitters should maintain this information in their files.

For certain device changes, the FDA believes that design control procedures can produce reliable results that can form the basis for a substantial equivalence (SE) determination without compromising the statutory and regulatory criteria for SE. Under design controls, manufacturers are required to conduct verification and validation (21 CFR 820.30(f) and (g)). Verification and validation include procedures to ensure that design outputs meet design inputs, and that devices conform to defined user needs and intended uses. The QS Regulation, 21 CFR Part 820, has records establishment and maintenance requirements that apply to design changes subject to design controls (21 CFR 820.30 and 820.180). These records must be made available to an FDA investigator upon request under section 704(e) of the FD&C Act.


Background

The FDA established the Special 510(k) Program in 1998 and described the program and policy in the guidance document "The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications" ("New 510(k) Paradigm Guidance"). The program was intended to create an efficient review process for certain changes subject to 510(k) submission requirements.

Design controls were added to the QS Regulation and have been in effect since June 1, 1997 (21 CFR 820.30, 61 FR 52602). The Special 510(k) Program leverages design controls requirements to support SE determinations through the reliance on risk analysis and verification and validation for existing devices. Special 510(k)s allow the FDA and industry to rely on previous Agency review of detailed information, where appropriate, without altering any statutory or regulatory requirements related to the premarket notification process under sections 510 and 513 of the FD&C Act, and 21 CFR 807 Subpart E. The Special 510(k) Program provides a least burdensome approach to the review of certain changes to a manufacturer's own legally marketed predicate device ("existing device") because a Special 510(k) provides an efficient pathway for manufacturers to provide the minimum required information necessary to establish SE for a modified device. Because of this efficiency, we intend to process Special 510(k)s within 30 days of receipt by the Document Control Center, rather than the 90 days for 510(k)s required by section 510(n)(1) of the FD&C Act.

The FDA's current approach for the Special 510(k) Program focuses on whether the method(s) to evaluate the change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format.

The FDA updated the Special 510(k) Program to clarify existing policy and the types of changes appropriate for the program to improve the efficiency of 510(k) review. Under this approach, certain changes to the indications for use may be made. The FDA has also clarified the types of changes to technological characteristics that are appropriate for review as a Special 510(k). For more information about how the FDA evaluates whether changes to the indications for use fall within the same intended use and how differences in technology affect the FDA's SE determination process, see the FDA guidance document The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. Special 510(k)s remain subject to the content and format requirements for 510(k) submissions, 510(k) summary or 510(k) statement, and class III certifications (21 CFR 807.87, 807.90, 807.92, 807.93, and 807.94, respectively).


When to Choose a Special 510(k)

If a new 510(k) is needed for the change, then summary information that results from the design control process may serve as the basis for substantial equivalence along with the required elements of a 510(k) found in 21 CFR 807.87.

A design or labeling change to an existing device (including certain changes to the indications for use) may be appropriate for a Special 510(k) when:

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

Appendix B of the guidance The Special 510(k) Program includes examples of changes that are and are not appropriate for review under the Special 510(k) Program.

If the FDA determines that a Special is not appropriate for review as submitted, the FDA intends to 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.


Content and Format of a Special 510(k)

In addition to the items required under 21 CFR 807.87 and 21 807.90, CDRH recommends that you refer to Appendix A of the FDA guidance document The Special 510(k) Program for the suggested format and content of a Special 510(k).

For additional information, see Content of a 510(k) and Format of a 510(k).


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 Special 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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