Feb 25, 2011

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) would see an appropriation of $329 million—a 4.8% increase over current levels—in the Obama administration’s proposed 2012 budget. Total CDRH funding would total $395 million, with $66 million from industry user fees, if the administration has its druthers, according to The Gray Sheet .

This is the second year in a row in which the White House has sought to fund the CDRH’s national device registry effort, this time to the tune of $4 million. The budget proposal also allocates $8.4 million to the CDRH for a medical countermeasures program to beef up the FDA’s response capabilities for new diseases as well as chemical and biological threats; $1.5 million to improve imported device safety; $1.7 million for increased medical device manufacturing inspections; and $1.2 million for staff training and research targeting nanotechnology. In addition, the CDRH would be allotted $49 million to promote innovation efforts and improve regulatory science standards. Of course, Congressional Republicans have other ideas when it comes to funding government agencies; the US House of Representatives has proposed cutting $241 million from the FDA’s overall budget. The two approaches will have to be reconciled before the FDA and CDRH’s 2012 funding will be finalized.

Author

  • Stewart Eisenhart

Related

CDRH Audit: Majority of NSE Determinations Due to Inadequate Performance Data from Sponsors

A recent audit of the Food and Drug Administration’s 510(k) program by the Center for Devices and Radiological Health (CDRH) has found that inadequate device performance data submissions from sponsors make up a substantial majority--80%--of Not Substantially Equivalent (NSE) determinations made by the agency between 2005 and 2010.

The analysis covered more than 700 NSE determinations made during the course of that six-year period. NSE determinations were based either on failure to provide appropriate performance data to support substantial equivalence (SE) determinations, or to demonstrate equivalent performance compared to predicate devices.

Read more

CDRH Process for Resolving Internal Medical Device Review Disagreements Needs Improving

Processes in place to resolve scientific disagreements among FDA medical device reviewers need stronger definitions and clearer lines of responsibility, according to the US Health and Human Service

Read more

CDRH Steps Up Vigilance of Genetic Testing Product Sector

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued letters to

Read more

Have questions on what Emergo can do for you?

CONTACT US