In the 510(k) arena, big changes are coming from FDA to speed the submission process. Don St. Pierre, Deputy Director for New Product Evaluation at the Office of In vitro Diagnostic Device Evaluation and Safety at CDRH explained a pilot program that triages 510(k) submissions at MD&M West this week. The program is only for IVDs at this time, but St. Pierre expects Christy Foreman (CDRH director) to roll it out to other device sectors eventually. The program is not intended to be interactive, but it holds industry and reviewers accountable for a quick review. St. Pierre provided a flow chart that explains the process:
Step 1: A company submits 510(k) with a user fee and an e-copy. If both the user fee and ecopy are correct the clock starts ticking. If something is wrong with any of the documents or fees, the clock is on hold, and FDA communicates the missing parts.
Step 2: Within 15 days, CDRH will have assigned the submission, and the FDA review begins. If there are any problems, FDA stops the clock and sends the submission info back to the company. If all is in order with the submission, the review moves on to step 3.
Step 3: Within 60 days the reviewer will open the substantive investigation. If there are problems at this stage, the reviewer will send a letter to the company. It will also work interactively with the firm to resolve any issues with the submission. If the SI review does not raise any flags, the FDA will engage with the company to resolve any linger questions.
Step 4: By day 90, the reviewer will have a final decision.
When it comes to making risk benefit determinations, FDASIA has changed CDRH. According to Randy Brockman, acting chief medical officer, how CDRH thinks about risk benefit determinations when it comes to PMA and de novo applications, has adjusted over the last few years. Essentially, he told MD&M West conference attendees, it’s not enough for FDA to think about the risks inherent in a clinical trial, it is just as important to understand the risks of not starting a clinical trial. That is, how many patients could affected negatively if a device is not allowed to move forward to prove safety and effectiveness. “This isn’t so much of a change, it’s just that the new regulatory structure allows us to formalize this point of view,” Brockman said. He also noted that if patients can accept the risks of a device, it is possible that FDA could find the trial approvable. As an example, Brockman said he could envision providing a subset of patients with a survey that informs them of mortality risks. If patients indicate through the survey that they would accept risks, CDRH can then better assess the rick/benefits of approving a trial.
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