Re-evaluation of the FDA Premarket Review Program

The FDA has implemented a plan that has increased its efficiency of its premarket application review. Some plans have been placed into action since 2010. The goal was to decrease the time it takes to clear a 501(k), reduce the backlog that has been pending for 90 days and reduce the average decision time. All of this is to be accomplished without reducing the quality of medical devices being approved.

When compared to the statistics from 2010, the average time has declined since 2005. The backlog has decline by two-thirds and decision times by almost one-third. Improvements in these areas would benefit patients and the medical device industry. The industry would be able to bring devices to market quickly. Costs would decrease for these companies and the patient would receive better healthcare.

Several other programs have also been created to support medical device innovation in the United States. These programs include the Innovation Pathway, Entrepreneurs-In-Residence, and incentives for medical device developers to perform their clinical studies within the United States.

REFERENCE: USFDA/CDRH. Improvements in Device Review – Nov 2012; WWW – 5 FEB 2013