The regulatory climate in the United States is changing dramatically. In addition to leadership changes at FDA and healthcare reform in Congress, there is uncertainty surrounding the regulatory pathway for medical devices. FDA has suffered some very public problems with the 510(k) process and has many stakeholders wondering what can be done to ease the regulatory pain.

FDA commissioner Margaret Hamburg admitted at the Reuters Health Summit in November that the agency’s device unit is “clearly troubled.” In addition, the commissioner said that she had heard from a variety of people in the device industry who were confused by some of the 510(k) system’s requirements.

“And I was hearing from investors that unless there was a more explicit definition of standards and expectations that it was increasingly unattractive to them to be investing in the medical device area,” she said.

The agency has commissioned the Institute of Medicine to assess the 510(k) pathway, and other changes that affect device OEMs may be on the way. Following the lead of several state governments, the federal government is also ready to pounce on improper gifts and payments made to physicians by medical device manufacturers. The Physician Payments Sunshine Act of 2009, which addresses transparency in the relationship between physicians and manufacturers, is currently circulating through Congress.

The passage of the Medical Device User Fee Amendments of 2007 (MDUFA) reauthorizes medical device user fees for FY 2008–2012. User fee rates for fiscal year 2010 have increased by 8.5%. These fees boost FDA’s resources and allow the agency “to pursue an ambitious set of negotiated performance goals,” according to commissioner Margaret Hamburg. FDA addressed the following key areas in FY 2008:

 

• Implementation of new performance goals for FY 2008–2012. The agency modified its business processes and implemented an interactive review program.

• Guidance to industry. FDA published six guidance documents related to MDUFA, including one required by statute and another three to meet FDA Commitment Letter requirements.

• Stakeholder communication and consultation. The agency focused on user fees and performance goals in its consultations with stakeholders.

• Overall performance. FDA is meeting or exceeding review times for actions completed on most performance goals.

 

In addition to FDA, MDUFA also benefits other stakeholders. For example, the agency says that safe and effective medical devices will reach patients faster and that manufacturers will receive more-consistent high-quality reviews.