Medical Device Regulation: Change is in the Air

Article preview from Medtech Insight- May, 2010

As the FDA revamps the medical device approval process, significant overhauls are expected for both the PMA and 510(k) pathways. Medtech Insight is presenting a series of articles focusing on the effect these changes will have to the industry, starting with this first installment focused on potential changes to premarket approvals.

Medical Device Regulation: Change is in the Air

Article preview from Medtech Insight- May, 2010

No one in the health care industry likes the uncertainty that change can bring, particularly when it involves alterations to product approval requirements that could make or break a business plan. This holds especially true for the medical device industry, which could be facing significant regulatory changes in the months and years ahead as the US Food & Drug Administration (FDA) works to revamp the device approval process. While changes aren't unusual when the FDA assumes new leadership, this time the impact could be particularly acute, given the recent passage of health care reform legislation and closer scrutiny of the premarket approval (PMA) and 510(k) filing processes.

The current FDA administration, which inherited a beehive (to put it mildly) from its predecessors, appears to have opted for the proactive approach. And, despite industry's concerns about regulatory change, significant overhauls are expected for both the PMA and 510(k) processes in the near future. In fact, so much has been planned that many are asking whether the agency's Center for Devices and Radiological Health (CDRH) has bitten off more than it can chew with its highly ambitious list of strategic priorities for fiscal year (FY) 2010.

In the first five months of 2010, the CDRH launched the first phase of a Transparency Initiative, held public hearings on the 510(k) process, issued new protocols for advisory committee meetings and members, and initiated several of its other time-bound strategic priorities. In the months ahead, the CDRH is expected to move forward with additional goals, which, along with the implementation of new health care reform initiatives and a looming new tax for device manufacturers, will likely create the perfect storm for industry. The long-term consequences could be felt far and wide, but the impact will be particularly severe for small, privately funded medical device companies.

New Requirements for Premarket Studies?

Potential changes to the PMA approval pathway that would make the process more rigorous have been bandied about for some time now. But no one was expecting change to come so soon; CDRH's FY 2010 goals call for the center to take "steps to improve the quality of clinical data submitted in support of PMAs" by the end of this year .

The PMA process is designed for more complicated and risky class III implantable devices and requires fairly extensive clinical trial data (compared to the 510(k) pathway, which utilizes predicate comparisons and is considered far less stringent). At issue is whether current PMA requirements go far enough, a concern fueled in large part by several high-profile device recalls that occurred over the past five years—particularly in the cardiac rhythm management arena. In fact, growing angst about device safety has been a major force prompting recent calls to revise the PMA process, which critics argue is too lenient. And two studies released in late 2009 that challenge the strength of trials used to support PMA filings for class III cardiovascular devices have only helped to fuel the fire.

The two studies—one published December 30, 2009 in the Journal of the American Medical Association ( JAMA) by researchers at the University of California, San Francisco, and the other an FDA-sponsored study published online on December 29, 2009 and in print in the January/February 2010 issue of the American Journal of Therapeutics ( AJT) —analyzed the quality of data used to support PMA filings between 2000 and 2007. Both call into question the breadth and depth of data needed to prove safety and efficacy for class III medical devices, pointing to data used to support PMA filings that is often inconsistent, incomplete, or under-representative of real-world patient populations. However, the authors reached far different conclusions about how to remedy the situation.

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