You might remember our prior post on FDA’s proposed expansion of the Abbreviated 510(k) Program. FDA recently issued a final guidance on this program with a brand-new name: Safety and Performance Based Pathway. Other than the new moniker, the final guidance does little to change the framework set forth in the draft. It does, however, provide some much-needed clarification on a few points. The draft guidance received 14 comments, and it appears the final version did a good job of taking these comments into consideration.
Overview of Framework
By way of background, for purposes of determining substantial equivalence in a premarket notification submission, section 513(i)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides that:
[W]ith respect to a device being compared to a predicate device, that the device has the same intended use as the predicate device and that the Secretary by order has found that the device –
(i) has the same technological characteristics as the predicate device, or
(I) has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including appropriate clinical or scientific data if deemed necessary by the Secretary or a person accredited under section 523, that demonstrates that the device is as safe and effective as a legally marketed device, and
(II) does not raise different questions of safety and effectiveness than the predicate device.
FDA has administratively established a few different flavors of 510(k) submission by which to demonstrate substantial equivalence: The Traditional 510(k), the Special 510(k), and the Abbreviated 510(k). The prior Abbreviated 510(k) program allows a sponsor to demonstrate some of the performance characteristics necessary to support a finding of substantial equivalence by showing conformity to FDA-recognized consensus standards. The revised program, dubbed the Safety and Performance Based Pathway, relies on the use of guidance documents, special controls, and FDA-recognized consensus standards to demonstrate all performance characteristics. In some circumstances, no direct comparison testing would be required. A predicate device would still be identified but testing of the proposed device would be conducted against objective performance criteria.
Devices Appropriate for the Safety and Performance Based Pathway
Not all devices are eligible for this Pathway. It is only appropriate when FDA has determined that:
(1) the new device has indications for use and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate,
(2) the performance criteria align with the performance of one or more legally marketed devices of the same type as the new device, and
(3) the new device meets all the performance criteria.
FDA intends to maintain a list of device types appropriate for the Safety and Performance Based Pathway on its website. Moreover, when FDA issues a guidance pursuant to this program to establish performance criteria for certain device types, the agency will identify the relevant product codes, appropriate intended uses, and appropriate indications for use that will be supported by the outlined performance criteria.
Identification of Performance Criteria
In addition to a list of device types appropriate for this pathway, FDA will publish the guidance documents that identify the performance criteria for each device type, as well as the testing methods recommended, if feasible. Sponsors should not use performance criteria in FDA-recognized consensus standards that have not been identified in FDA guidance as suitable for this program.
When selecting performance criteria and test methodology or establishing new performance criteria and test methodology through guidance, “FDA intends to rely on the experience and expertise of FDA staff, information in literature, and analyses of data available to FDA on existing devices within a device type to determine the performance criteria and associated testing methods that could support a finding of substantial equivalence for a given device type.” The draft guidance did not mention that FDA would rely on potentially confidential data from prior 510(k) submissions. Although FDA is not permitted to disclose these data outside the agency (21 C.F.R. § 807.95), they already make use of them for comparative purposes in 510(k) reviews (e.g., in deciding what testing parameters they will accept).
FDA Review of Data
In response to a comment, FDA provided a table summarizing the amount and type of information necessary to support a finding of substantial equivalence:
Type of Performance Criteria and
Methodology FDA identified in the relevant
Safety and Performance Based Pathway
Safety and Performance Based
Pathway 510(k) Submission should
|Performance Criteria||Testing Methodology|
|FDA-recognized standard||FDA-recognized standard||· Declaration of Conformity|
|FDA-established||FDA-recognized standard||· Summary of Data
· Declaration of Conformity to recognized standard for methodology
|FDA-established||FDA-recommended or specified||· Summary of Data
· Testing Protocol
|FDA-established||None specified/recommended or alternative to FDA-specified methodology used||· Summary of Data
· Underlying data
· Testing Protocol
The reference to “FDA-recognized standard” refers to FDA-recognized consensus standards indicated in the relevant Safety and Performance Based Pathway guidance for use for a particular device type. Performance criteria in FDA-recognized consensus standards that have not been identified in FDA guidance for use in the Safety and Performance Based Pathway should not be used in this program. However, with respect to test methodologies, although FDA may recommend a test methodology for the performance criteria, a submitter may choose to use an appropriate testing methodology other than what is specified or recommended to demonstrate the performance characteristics.
One big question mark from the draft guidance was how a change in the eligible devices impacted those products already on the market or those products with pending submissions. FDA clarified that, when there is a change, such as when a device type is removed from the list or an updated final guidance is issued, the change would apply prospectively to devices for which a 510(k) has not yet been submitted. For example, if a 510(k) is submitted for a device type before FDA determines that device type is no longer eligible for the program, the device will still be reviewed under this framework. However, FDA notes that the device may be subject to other action, as appropriate, to address the reason for the modification or removal from the eligibility list, for example, if there was a safety concern.
We remain optimistic that this expanded pathway will be useful to industry and allow for greater efficiency and decreased testing burdens on certain device types, though we suspect that most device types will likely not be eligible, i.e., it will be a niche pathway. It remains to be seen how quickly FDA can issue the product-specific guidance, especially given the disruption from the government shutdown earlier this year.