On September 28, 2018 FDA issued a new draft guidance document: The Special 510(k) Program (“draft guidance”). The draft guidance was followed by the announcement on October 1, 2018 of a Special 510(k) Pilot Program. The Special 510(k) program was established in 1998 to create a streamlined review of technological changes made to a manufacturer’s own cleared device, leveraging design control requirements. In its current form, changes reviewed under the Special 510(k) program are limited to those that do not affect the intended use of the device or alter the fundamental scientific technology.
The draft guidance and pilot program propose different criteria for submission of a Special 510(k) than used for the current program. The program is still limited to changes made to a manufacturer’s own device. However, instead of focusing on changes that do not affect the intended use or fundamental scientific technology, the draft guidance and pilot program focus on the types of testing needed to evaluate the change. A new flowchart is provided that one can envision being used as part of a manufacturer’s change control process to evaluate whether a change to an existing device should be submitted in a new 510(k), and if so, if a Special 510(k) may be appropriate.
A Special 510(k) would be appropriate for changes where performance testing is either not needed, or where performance testing is needed, there is a well established method to evaluate the change and data can be reviewed in a summary or risk analysis format. A “well established method” would include methods, protocols and acceptance criteria from the previously cleared 510(k), methods in an FDA recognized standard and/or widely available and accepted methods published publically or found acceptable in a referenced 510(k) clearance, granted De Novo classification request or PMA approval. According to the draft guidance, however, a number of additional considerations are provided that should also be considered in determining whether the Special 510(k) pathway may be acceptable.
A description of the content of a Special 510(k) is also proposed, which appears similar to that recommended in the current program. A concise summary of design control activities and summary of test methods, acceptance criteria and results are provided instead of complete test reports. As FDA has stated that all Special 510(k)s received on or after October 1, 2018 will be included in the program pilot, sponsors preparing Special 510(k) submissions according to current guidance should look closely at the new guidelines prior to submissions to avoid conversion to a Traditional 510(k). Additionally, sponsors currently preparing Traditional 510(k)s for changes to their existing devices should look at the new criteria to determine if they may now be eligible for a Special 510(k) under the pilot program. As with the current program, it may take sponsors more time to prepare a Special 510(k) than a Traditional 510(k), because more time may be needed to summarize activities and data in the recommended format. The reduced review time will likely be worth the extra effort.
It is hard to predict if the new program will result in an increase in the number of device changes that can be submitted as Special 510(k)s. FDA’s pilot program is intended to test the process to determine if it can achieve FDA’s goal of an increase to the number of 510(k)s appropriate for the Special 510(k) program. Because the draft guidance clarifies which changes will be appropriate for the program, the number of Special 510(k)s converted to Traditional 510(k)s may decrease, which could reduce a significant source of uncertainty in the review timeline.