In September 2018, the United States Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released a draft guidance laying out some changes to the Special 510(k) program. The Special 510(k) program was created in 1998 and attempts to streamline the FDA’s review of 510(k) submissions. Manufacturers who are planning to change their own legally marketed device can utilize risk analysis, verification, and validation activities to help facilitate the submission, review, and clearance of the change.
To improve the efficiency of the Special 510(k) program, the FDA is trying to update it to clarify existing policy and expand on device changes that are appropriate for the program. When finalized, the guidance will explain the updated factors the FDA intends to use when considering whether a 510(k) is appropriate for review as a Special 510(k).
The proposed device eligibility expansion in the draft guidance is intended to help FDA review staff meet a goal set as part of the latest authorization of the Medical Device User Fee Act to reduce the average total time to decision for 510(k) submissions to 108 calendar days by FY 2022. The incentive to choose the Special 510(k) option is that the FDA review time is trimmed down to no more than 30 days of receipt consistent with the least burdensome principles of the Federal Food, Drug, and Cosmetic Act (FD&C Act), plus complete test reports are not required. In contrast, 510(k)s submitted under the Traditional 510(k) Program are to be reviewed within 90 days.
To demonstrate substantial equivalence (SE) of a modified medical device to one that has been released for commercial distribution in the US, the draft guidance points to an updated flow chart for the decision-making process in determining whether a special 510(k) is appropriate.
If agency review staff do not agree with a case made by a submitter that its proposed device modification can be evaluated via a special 510(k), FDA intends to convert the submission to a traditional 510(k). The conversion process “can result in delayed review.”
All comments were due to the FDA by November 27, 2018, and now that they are in, there seems to be mixed reactions and feelings to the proposed changes.
By and large, commenters supported the move to update the 1998 policies as the special 510(k) approach can save time and money as compared to traditional 510(k) submissions. However, they tended to argue that the proposed expansion framework may actually hinder greater program participation due to a lack of consistency, clarity and transparency around the drafted framework and CDRH internal processes.
The main concern among several device companies revolves around a lack of clarity around the process used by agency staff to determine whether a submitted special 510(k) will be converted to a traditional 510(k) prior to being reviewed.
Medical device manufacturers Fresenius Kabi USA and Cook Group called on the CDRH to address the abbreviated 510(k) program in the special 510(k) draft guidance. They pointed to draft guidance CDRH issued in Summer 2018 that proposed an expansion of its abbreviated 510(k) program.
In addition, the commenters suggested implementing new policies and procedures under the expanded special 510(k) program to deliver on transparency. These include a new process that can be used by an applicant if a CDRH rationale for special 510(k) conversion is “questionable,” a “defined mechanism” to obtain feedback from CDRH and an “option to have an early consultation meeting” with agency staff.