Ronald S. Warren
As we enter 2010, much uncertainty remains about how personnel and policy changes at FDA and CDRH may impact the medical device industry. In 2009, there were a number of shifts at the agency that could transform the regulatory landscape for device and diagnostic manufacturers in the United States.
First and foremost was the appointment of Margaret Hamburg, MD, as FDA commissioner. In her first year at the head of the agency, she has highlighted the need for improved food safety and has promised increased enforcement and faster agency action for device violations. Moreover, she has publically stated that CDRH has had significant troubles and that big changes are in order for the device review process. Some of the CDRH troubles stem from the controversy related to the 510(k) approval of a knee-repair device. Claiming that the scientific review of this application had been compromised, disgruntled CDRH employees wrote to Congress asking for an investigation into potential industry influence. Later in the year, former Commissioner von Eschenbach admitted that FDA was under undue pressure and influence in the ReGen Menaflex 510(k) clearance. In the shadow of this controversy, long-time CDRH director Dan Schultz resigned and has been replaced with Acting Director Jeffrey Shuren.
Under new leadership, FDA has promised to evaluate the decision-making process with CDRH, and, in particular, the policies and process related to 510(k) reviews. The agency has engaged the Institute of Medicine to perform an audit of the 510(k) process, a $1.3-million program underway through 2011. The aims of this audit are to focus on postmarket research, to increase transparency and to establish clear procedures to resolve differences in FDA decision making. Furthermore, the agency has initiated its own internal review of the 510(k) process, and ODE Director Donna Bea-Tillman has asked device branch chiefs to flag devices that raise new questions of safety and effectiveness or have new intended uses.
In addition to changes within FDA, there are significant external forces that may result in other changes. For example, early in the year the General Accounting Office reported that the 510(k) program was inappropriately used to clear hundreds of products. Last year, Congress called for FDA to finalize classifications on pre-amendment devices, and the House and Senate held hearings on the device review process. Legislatively, there are pending bills related to food safety and possible changes in preemption rules related to device liability laws.
It was a distressing year for the agency. In my view, these changes have created ongoing challenges for companies seeking to get clear guidance on timely approvals of product premarket applications. The implications for 2010 include a slowdown in some reviews and requests for information by review staff particularly for devices with new intended uses or technological characteristics. Industry should also expect to see more enforcement action, particularly for postapproval obligations and in areas where the agency has employed "enforcement discretion" (molecular diagnostic tests, for example). In the longer term, devices are more likely to be classified upward—PMA instead of 510(k)—where there are no clear predicate devices or where there is an expansion of claims and intended use.
The ongoing issues at FDA will take some time to play out. In the meantime, companies are well advised not to "push the envelope" on product claims or ignore their postapproval obligations. Companies with innovative products should take advantage of early collaboration meetings (i.e., pre-IDE process) with CDRH. It will not be surprising if we see a trend in premarket applications requiring more clinical data for Class II devices, and more PMA applications required for innovative or higher risk products. While the coming year will likely result in more industry frustration, companies can benefit from careful regulatory planning and early communication with CDRH on product submissions.
Ronald S. Warren is a principal consultant in the regulatory services group at MDCI, a full-service CRO and regulatory consulting firm focused on the medical device industry. He has more than 22 years of regulatory and clinical affairs experience, with specific expertise in IVD products, human-derived tissue-engineered products, and cardiovascular devices. He has coordinated and led multiple pre-IDE meetings and been involved in the submission and preparation of PMAs, 510(k)s, PMA supplements and IDEs for various clinical indications. Find out more about the company by viewing its listing in the Consultants Directory or by going to its website.