On December 31, regulatory and reimbursement agencies will be hit with another sequestration cut - an additional 5% line-by-line cut to reach the mandated total 15%. These cuts will remove smaller innovative initiates, and cripple new efforts to bring efficiencies with new technologies and infrastructure.
The FDA CDRH budget is primarily funded by appropriations; therefore, they will have to tighten their belts when the next round of sequestration begins January 1st. These cuts will remove smaller innovative initiates, and cripple new efforts to bring efficiencies with new technologies and infrastructure.
As FDA prioritizes the review of applications utilizing current infrastructure, the impact to medical device companies will be a higher risk to traverse through the application process. Companies that are aware of the impacts of these cuts unfortunately are already reducing their risks by postponing applications that are for more innovative, and hence riskier, healthcare device solutions.
Getting through regulatory approval as soon as possible is always the goal for any medical device company. It is critical for applications submitted to FDA to succinctly address sound scientific methods and clearly address each section of the application. Approval applications which provide comprehensive and scientific approaches, and thoroughly address questions of risk and safety, will proceed to clinical trials more effectively. Both FDA and the device companies benefit from thorough and complete applications.
Finding efficiencies and innovative approaches with limited resources will challenge both the FDA CDRH and the device companies.
-- Vizma Carver, Founder and CEO
ClearRoadmap: www.clearroadmap.com a product of Carver Global Health Group