FDA wants 11% budget increase for device unit

FDA Commissioner Margaret Hamburg

The FDA is requesting about $870 million to run the Center for Devices and Radiological Health (CDRH) in the next fiscal year, an 11% funding increase over 2012 that the agency says will speed up approvals of new technology.

The request, part of President Barack Obama's fiscal 2014 budget proposal, tabs about $151.6 million for approvals and clearances and around $39.9 million for post-market safety. The rest is largely divided between radiation compliance enforcement, IT investments and mammography monitoring.

The agency's budget request comes with some performance benchmarks for CDRH, aiming to review and decide on 80% of PMA applications within 180 days of filing and 93% of 510(k)s within 90 days. According to most recent numbers, the agency rules on about 60% of PMAs in 180 days and 90% of clearance requests in 90 days.

CDRH says it'll need the whole $151.6 million--$39.5 million more than it got in 2012--and 80 new full-time equivalent workers to meet the goals.

Included in the FDA's request is the already-approved uptick in user fees, doubling what devicemakers pay for approvals through a bill Obama signed back in July. On the whole, the agency wants $4.7 billion in the next fiscal year.

"These are tight budget times, and the FDA budget request reflects this reality," FDA Commissioner Margaret Hamburg said in a statement. "Our budget increases are targeted to strategic areas that will benefit patients and consumers and overall strengthen our economy."

The industry has by and large supported the FDA's plan to scale up spending and cut back on approval times, praising the agency for recognizing its sluggishness and trying to move things forward. Of course, it remains to be seen whether the FDA's plan will actually result in a speedier process for the thousands of companies slogging through PMA and 510(k) process.

The request is part of Obama's $3.77 trillion budget proposal for the 2014 fiscal year, which is about $14 million smaller than the government's estimated FY 2013 spending.

- read the FDA's budget request (PDF)
- check out the agency's statement