CDRH Report Includes Promises to Improve Culture

As if to preempt external examination of its internal workings, CDRH included in a report on its premarket review programs a promise that it is going to “create a culture change toward greater transparency, interaction, collaboration, and the appropriate balancing of benefits and risks.”

In the l0,000-word report released in October, the agency lists improving its culture as a top priority. It writes that it will accomplish this through “better engagement with industry; greater use of external experts; implementing flexible, risk-based policies that appropriately balance benefits and risks and apply a more patient-centric approach; establish-ing new ways of doing business that add value; and setting clear expectations for CDRH staff.”

The report gives little insight into why the center allowed its culture to reach the point in which it needs to be changed; neither does it indicate what the cost of such change will be. Obliquely, it hints that improvements can come about through the smarter use of existing resources and through unspecified additional assistance from the user fees that are currently being negotiated.

Asserting that the agency’s diverse scientific staff is “dedicated to protecting and promoting the public health,” the report says CDRH’s employees also “share(s) industry’s desire to bring safe and effective devices to market quickly.”

Given the rapid advance of technology and science, the increasing attention being paid to evidence-based medicine, and increasing patient involvement, “all members of the medical device ecosystem must refocus,” the report reads. Interestingly, the report mentions that because many devices come from “small, entrepreneurial companies that are flexible, dynamic, nimble and quick,” CDRH should “become more entrepreneurial.”

Industry is perpetually complaining about the unpredictability and inconsistency in the review process. Perhaps as an answer to those complaints, CDRH says it will work to address those issues by taking the following steps:

The report says CDRH should try to maintain a level of flexibility that will enable it to adjust and improve as needed. It also says the center should collaborate with companies to improve the quality of submissions and work to ensure it has the necessary resources to perform its functions. Each of the actions described in the document has either already been implemented or will be implemented, at least in part, within the first half of 2012.