Medical Device Link.

MD&M Minneapolis 2009

It’s time for manufacturers to prepare for a new era of compliance, says Michael Barile, founder and partner of the medical device consulting company Barile & Associates Inc. (Clinton, NJ).

Barile will chair the conference session “The Future is Now—Anticipating a New Era of FDA Enforcement” at MD&M Minneapolis. Running October 20–21, the session will be held at the Minneapolis Convention Center.

A recent development during Hamburg’s tenure is the resignation of CDRH director Daniel Schultz. Under his leadership, some agency scientists criticized management for letting industry concerns influence the device approval process. Barile says that Hamburg has made it clear that agency policy should be shaped by science instead of relationships with industry and politicians. With her at the helm, “we certainly can expect approval and clearance decisions that avoid the specter of such management intervention,” he says.

In addition to tightening the device approval process, Hamburg also wants to reform the agency’s compliance enforcement program. Armed with a historic operating budget for 2010, FDA may have the funds to carry out Hamburg’s goals, Barile says.

Speaking to FDLI in August, Hamburg outlined steps to increase enforcement action. Examples include setting postinspection deadlines for company’s corrective actions, issuing warning letters at a quicker pace, and cooperating with international and local authorities to speed enforcement action.

Barile says that these proposed steps indicate a return to a “more aggressive, pre-Bush administrative posture,” which could endanger companies that are lax about compliance. More troubling is that it could negatively affect device manufacturers that display a “mainstream compliance profile.”

“What has come to be considered ‘mainstream compliance’ may prove to be ‘marginal compliance’ within the agency’s more enforcement-minded posture,” Barile says.

Of course, determining how Hamburg’s tough talk will translate into practice is a major challenge for manufacturers. Barile says that his clients have expressed concern that their quality systems, which previously satisfied field inspectors, will now trigger a list of 483 findings.

To get a grasp on this uncertain terrain, Barile advises companies to look at the continuum of FDA’s evolving expectations. “The bar that we in industry need to leap over goes up over time.” 

Reading warning letters, the FDA Enforcement Report, and recent FDA draft guidances are good ways for companies to project the agency’s changing expectations, Barile says. It is especially important for large companies to start taking action now because it is difficult for them to quickly enhance their quality systems.

Supplier controls and risk management are two of the areas in which Barile predicts a definite change in enforcement policies. He plans to discuss these topics in-depth at his MD&M Minneapolis session. To learn more about this session and the others offered at the event, visit www.mdmminn.com.