The medical device industry largely supported a move to more than double what it pays for FDA approvals over 5 years, in part because the agency promised to quicken the process all around. Now, the FDA says it has already done just that, and it has a plan to keep improving.
The agency released a report this week updating the progress of its "Plan of Action," a multistep move to become more agile and responsive. According to the FDA, the average time time it takes to decide on a PMA has dropped by one-third from its high in 2010, and the average time for 510(k) rulings is on the decline for the first time since 2005. Furthermore, the number of 510(k) apps found to be substantially equivalent rose to 80% this year, a 9% increase the FDA says it achieved without lowering standards.
And it's still early the process. The FDA says it has met its implementation guidelines so far but plans to go further, adding 200 staff members and streamlining its reviews to decrease application backlogs and trim timelines for pending devices.
The internal report is quick to pat the agency on the back for its efforts, but members of the industry have said that while the FDA is on the right track, it's not moving fast enough. Average wait times have come down, but many devicemakers still get stuck in the slog of delayed, postponed and protracted approval process, and a host of Minnesota companies have filed a petition asking the FDA to focus on short-term fixes as it prepares for broader changes.
As ever, though, the FDA is beset by conflicting pressures. While the industry bemoans a sluggish process that damages revenue, some lawmakers and consumer groups say the agency's policies are too lax. Rep. Edward Markey (D-MA) and Sen. Jeff Merkley (D-OR) have asked the agency to toughen up its 510(k) regulations, worrying that companies can get clearance based on previously recalled devices, possibly putting patients in danger.
- read the FDA's report (pdf)