Lawyer: How to Lift 510(k) Transparency

A way to add transparency and predictability to the 510(k) decision process would be for Congress to require CDRH’s Office of Device Evaluation (ODE) to use the premarket decision summary template started in 2003 by the Office of In Vitro Diagnostics (OIVD) and still used today. That’s the opinion of attorney Jeffrey Shapiro (Hyman, Phelps & McNamara), writing in his firm’s FDA Law Blog.

Shapiro says the issue of creating a more complete database of 510(k) decisions is highlighted in the House FDA Reform Act of 2012 (HR 5651), which would require FDA to “regularly publish detailed decision summaries for each clearance of a device requiring clinical data.” The requirement would apply only to new clearances. The provision is not in the companion Senate Food and Drug Administration Safety and Innovation Act (S. 3187).

After reviewing the nature of the 510(k) decision system, Shapiro notes that a persistent criticism of it has been that there is a lack of predictability, particularly as to the data that will be required to bridge the gap between proposed and predicate devices.

He says a root cause of the problem may be a lack of transparency due to inadequacies in the database of 510(k) summaries. Entries are prepared by the submitter, rather than by FDA, and are not well standardized and tend to be vague and lacking in detail, he says. While the agency has forced improvements in the last couple of years, not enough has been done, Shapiro contends.

“The bottom line is that the public is operating from a different and degraded database as compared to FDA reviewers, who have access to complete 510(k) files and also have institutional knowledge of their prior decisions,” he writes. “The current lack of access to important decision data creates a cloudy picture that leads to unpleasant surprises when FDA reviewers impose data requirements that were not discernable from the public 510(k) summaries.”

Shapiro says the provision in the House legislation is “too timid” and should be extended to require decision summaries for all new 510(k) clearances and not just those requiring clinical data.

He then points to the OIVD Premarket Decision Summary Template that summarizes the basis on which an in vitro diagnostic device was cleared under a 510(k) submission. He says the summaries have been continuously posted on the OIVD Web page and the public has full access to them through the 510(k) database.

“Congress should simply require FDA to extend this useful practice to ODE,” Shapiro says. “If ODE lacks sufficient resources, then Congress should provide the necessary funding. However, it is not obvious that such funding is needed. The ODE reviewers undoubtedly document their review decisions now. It should not require significant additional resources to create a standard template, complete it for each 510(k) review, and post it to the 510(k) database.”