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  1. Premarket Notification 510(k)

Safety and Performance Based Pathway


Overview

There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional; Special; and Abbreviated. The Safety and Performance Based Pathway is an expansion of the concept of the Abbreviated 510(k) pathway for certain, well understood device types.

Under the Safety and Performance Based Pathway, a medical device manufacturer has the option to use FDA-identified performance criteria to demonstrate that a device is as safe and effective as a predicate device. The use of this pathway does not affect the FDA's ability to obtain any information authorized by the statute or regulations. For more information refer to the guidance Safety and Performance Based Pathway.

What device types are appropriate for the Safety and Performance Based Pathway?

The Safety and Performance Based Pathway is appropriate when the FDA has determined:

  • The new device has the same indications for use as, and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate; and
  • The new device meets all the FDA-identified performance criteria.

If any of the above factors are not met, the submitter has the option to submit a Traditional, Special or Abbreviated 510(k).

The following final guidances identify performance criteria and testing methodologies for device types that are appropriate for this pathway:

The FDA will continue to issue draft and final guidance(s) to apply this Safety and Performance Based Pathway to additional types of devices with corresponding FDA-identified performance criteria. Industry may suggest device types for which the FDA should consider identifying performance criteria. For example, industry may suggest devices for which there are comprehensive FDA-recognized consensus standards. We encourage industry and other stakeholders to submit evidence-based suggestions on what the performance criteria should be for eligible device types. Input can be provided using the docket number FDA-2018-D-1387 at www.regulations.gov.

The FDA issued draft guidances identifying performance criteria and testing methodologies for the following device types. Once these guidances are finalized, submitters will have the option to use the safety and performance based pathway for these device types.

How to prepare a 510(k) using the Safety and Performance Based Pathway

The amount and type of information necessary to support a finding of substantial equivalence under the Safety and Performance Based Pathway will depend on the underlying source for the performance criteria and testing methods. Table 1 and the Appendix within the Safety and Performance Based Pathway guidance summarize the types of information that should be included in a submission based on the submitter's approach. Submitters should also refer to relevant device-specific Safety and Performance Based Pathway guidance for more information. The FDA recommends submitters clearly state in their 510(k) cover letter that their submission is intended for the Safety and Performance Based Pathway.

Importantly, 510(k) submitters still need to identify a predicate for certain aspects of substantial equivalence. However, instead of conducting direct comparison testing to demonstrate a device is as safe and effective as a predicate device, manufacturers will have the option to use this pathway to demonstrate substantial equivalence, when appropriate.

How to submit a 510(k) using the Safety and Performance Based Pathway

510(k)s using the Safety and Performance Based Pathway must be submitted in an electronic format (eCopy). After a 510(k) is received by the FDA, we do NOT return the submission or any copies to the submitter.

Requests should be sent to the appropriate Document Control Center. The current mailing address for CDRH’s Document Control Center is provided on the eCopy Program for Medical Device Submissions webpage.

We recommend submitters send 510(k)s to the FDA by a method which will provide a signed receipt of delivery, for example, registered mail with a return receipt or a commercial delivery service. Submitters should receive an acknowledgment letter from the FDA, including the assigned 510(k) number, within one week of delivery.

What are the MDUFA User Fees associated with a 510(k) using the Safety and Performance Based Pathway?

All 510(k) submission types including those submitted under the Safety and Performance Based Pathway require the 510(k) review fee. Information on how to submit the fee can be found at Medical Device User Fees.

What is the FDA Review Timeline?

The FDA goal to make a MDUFA Decision for a 510(k) using the Safety and Performance Based Pathway is 90 FDA Days. For more information, refer to the 510(k) Submission Process that describes the review process after the submission is received by the FDA.

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