A study in the October issue of the journal Health Affairs could fuel the debate over whether the U.S. Food and Drug Administration (FDA) has been bringing medical devices to market in a timely manner and if the Centers for Medicare and Medicaid Services (CMS) has been meeting its deadline for national coverage.

Study findings reveal that the FDA's median time for approval never achieved its statutory deadline on a consistent basis nor did CMS'. The law requires a deadline of 180 days for approval of premarket applications and national coverage.

Since 1997, Congress has passed a series of laws that have given the FDA deadlines to evaluate the safety and effectiveness of class III medical devices--those that have the most stringent regulations and pose the most harm to patients--in order for them to be approved for market use. Specifically, Congress enacted the 1997, 2002 and 2007 modernization laws because the FDA had issues meeting the statutory deadline set forth by Congress in 1976, which said that the FDA must review all premarket applications within 180 days. In a nutshell, these modernization laws aimed to speed up the process of approval, all the while making sure the agency had adequate resources to do so. In addition, The Food and Drug Administration Safety and Innovation Act, signed into law in 2012, gave the FDA the authority to collect user fees from medical device manufacturers. In the Medicare Modernization Act of 2003, Congress mandated that CMS review all national coverage applications within 180 days, or within 270 days if an application required more.
Study authors conducted the analysis to "document and assess the effects of FDA and CMS modernization reforms in terms of time (calendar days) to approval," according to the report.

After reviewing all class III FDA approvals for premarket applications and all CMS approvals of national coverage from 1995 through 2008, many of which had to be manually reviewed to locate dates, study authors found that although the FDA made an effort to meet the 180 day deadline, it managed to do so with fewer than 20 percent of the premarket applications. CMS median approval times, however, decreased steadily over the study period, but overall, were unable to meet the deadline consistently.

The FDA data set included 455 approvals whose dates were evaluated in the study. Only one record was excluded because of an error with its start date. On the other hand, the CMS data set consisted of 89 coverage decisions, of which 65 other decisions were excluded because of missing start dates, something the report identifies as affecting "the premodernization analysis but not the postmodernization analysis."

Study authors conclude that both agencies should work toward improving their respective databases to allow for accurate reporting of long-term trends in these data. This, they say, will give policymakers the tools to better understand why statutory deadlines are not being met and what future adjustments to the legislation might be necessary.

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