The author proposes three ways to streamline the 510k process through self surveys, scorecards, and modular submissions.
Modular submissions are already used for PMA submissions. Self-surveys and scorecards are tools that most companies utilize to evaluate vendors. Why not implement these solutions to make 510k reviews more efficient?
A few weeks ago, I posted a blog about the Triage pilot program at the FDA. I received some great comments by email, and this blog discusses this subject more in-depth with some specific ideas for streamlining the 510k process. Here’s the argument for considering these three proven methods:
In my previous posting about the Triage pilot program, I suggested using the existing FDA traditional 510k screening checklist and converting this into a similar “SmartForm.” Another way to think of this concept is by comparing it with a “Self-Survey.” Companies send Self-surveys to suppliers to gather information about the supplier as justification for approving them; Elsmar Cove has some discussion threads specific to the supplier self-surveys if you are unfamiliar with this method of torture. The critical step in the design of surveys is to require the submitter to provide references to procedures and forms, or to explain why something is not applicable. BSI uses this same strategy for its auditor combined checklists. Instead of checking “yes/no,” the auditor must reference a page in their audit notes where the objective evidence of conformity or nonconformity can be found. A submitter should fill in the checklist, rather than an FDA reviewer because this forces the submitter to verify that everything required is included. Canada has a similar requirement called a “submission traceability table” for Medical Device License Applications (see Appendix A). Self-surveys also replace some of the tedious searchings by a reviewer with cross-referencing work by the submitter.
Another tool that supplier quality uses for supplier evaluations is the Scorecard: Elsmar Cove has a few discussion threads, including one with an example to download. For the 510 processes, I suggest developing scorecards for both the reviewer AND the submitter. The primary metrics for these scorecards would be on-time delivery and completeness of the submission for a submitter. “On-time delivery” requires advanced planning and communication of the submission with the FDA. This is important so that the FDA has adequate time before submission to identify the best reviewer(s) for the submission. The completeness of the submission should be 100% of a self-survey, SmartForm, or checklist used to prepare the submission. The primary metrics for the reviewer would be on-time completion and accuracy of the review.
The FDA already has target turn-around timescales for decisions (i.e., – 90 days), but there are different phases of review and multiple people the are involved in the reviews. Therefore, the measurement of reviewer time should be more granular. The accuracy of the reviewers should be validated by requiring all deficiencies to be re-evaluated by a peer or superior before involving the company. Submission sections without any findings should also be reviewed on a sampling basis as a double-check. Over time, the FDA should be able to use these scorecards to match up a reviewer with a submitter. It is critical that at least one of the parties is experienced, so we don’ t have the “blind leading the blind” situation. For those that are offended by the concept of a required second reviewer–get over it. Radiologists are periodically graded with images that are “red herrings.”
My third suggestion is to consider adopting some of the Premarket Approval (PMA) processes for the 510k process. In particular, pre-IDE meetings and modular submissions seem to be logical process improvements. There is typically one component of the submission that is a little behind the rest and can delay a submission. Under the current system, nothing is submitted or reviewed for a 510k, unless it is complete. However, it would enable companies to get new and improved products to market faster if submissions were modular. Validation, such as shelf-life and sterilization validation, is rarely the cause for a “Not Substantially Equivalent” (NSE) letter, but these tests are routinely the last few reports completed for submission.
Adopting a modular submission process for 510k would allow companies to submit sections of the submission as they are completed. This modular approach would alleviate the time pressure on both sides, and this proposed change should result in earlier product launch dates for the industry. The other component of this process is the pre-IDE Meeting. Before initiating a clinical study, companies will submit a plan for the study to the FDA. The intent is to obtain agreement on the validation testing that will be performed by the company–including the number of patients and the design of the clinical study. These meetings would also be valuable for 510k submissions where the company and the FDA need a forum to discuss what verification and validation testing will be required–especially for mixed-predicate devices and devices that are significantly different from a predicate device.
What do you think about these proposed changes to the 510k process?
Please share your own ideas for streaming the 510k process–including any comments regarding the FDA’s plans for change.