During March 13 testimony before a Senate committee, Food and Drug Administration Commissioner Margaret Hamburg, M.D., defended the length of time it takes the regulatory agency to review and approve medical devices. "I can assure you that the FDA review teams take their job very, very seriously, going through in a systematic way the data that's available to them, assessing safety, efficacy and overall risks and benefits to patients," Hamburg testified.
"Since fiscal year 2010, we've achieved a 27 percent decrease in the backlog of lower device applications and a 10 percent decrease in average total review time," she told the Senate Health, Education, Labor and Pensions Committee. "For higher risk devices, we've seen a 43 percent decrease in the backlog and a 32 percent decrease in average total review time."
The FDA chief said that the agency is at the "cutting edge in terms of review and approval of new products" compared to the rest of the world. "If you look at drugs approved in recent years, I think about three-quarters of them were approved in the United States first and on devices, apart from the highest risk devices, we are I think at par with comparable other countries in terms of review times. We do ask for more clinical data often on the higher risk devices. But, I think there's some urban mythology about where we stand in comparison to review times and leadership."
Since the late 1990s, Hamburg said the FDA has cleared more than 75 mobile medical apps. At last month's HIMSS14 conference, FDA senior policy advisor Bakul Patel told an audience that in 80 percent of the cases the regulatory agency has met the statutory 90-day timeframe to review mobile medical apps under the 510(k) process. In September, the FDA published its final guidance on mobile medical apps.
"Consistent with FDAs existing oversight approach, which considers functionality rather than platform, the agency intends a tailored approach [to mobile medical apps]," Hamburg testified before the Senate committee. "The agency intends to exercise enforcement discretion for the majority of mobile apps as they pose low risk to consumers. FDA intends to focus its regulatory oversight on the subset of mobile apps that are medical devices that present risks to patients if they do not work as intended."
However, some industry groups and members of Congress support a legislative effort to amend the Federal Food, Drug and Cosmetic Act, which they argue is outdated in its definition of what constitutes a "medical device" under FDA oversight. In a recent Roll Call op-ed, Joel White, Executive Director of the Health IT Now Coalition, charges that "regulators seem to believe the old regulatory framework, created when most used typewriters and carbon paper, is well-suited to ensure mobile apps are safe and effective." Not so, according to White. "I am glad some in Congress are gearing up efforts to rewrite the decades-old framework, because a smart, risk-based regulatory structure can lower costs, improve health outcomes, and foster innovation that creates jobs," he wrote. "The federal regulatory structure for health IT was crafted and passed in the 1970s."
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