we implemented process changes to our Investigatio

we implemented process changes to our Investigational Device Exemption (IDE) program, consistent with FDASIA. Our 2013 draft guidance on FDA Decisions for Investigational Device Exemption Clinical Investigations ⁴ proposed additional program modifications to allow earlier and more efficient clinical study enrollment. These efforts are an extension of our 2012 guidance that describes the explicit factors we consider in making certain types of premarket benefit-risk determinations ⁵ , including patient preferences on the benefit-risk tradeoffs of potential treatments.

We have already seen substantial impact. For example, the percentage of IDE submissions that received an approval decision authorizing study initiation (i.e. an IDE conditional approval or full approval decision) within two IDE cycles increased from 46 percent in FY 2011 to 77 percent in FY 2013, while the median time to full study approval was reduced from 435 days to 174 days.

In addition, we continue to improve the clinical trial ecosystem in the U.S. through collaborative efforts, such as the Medical Device Innovation Consortium’s Clinical Trial Innovation and Reform Project ⁶ , which have the potential to improve the efficiency of the clinical study process leading to earlier access in the U.S. to beneficial innovative technologies for patients.
http://www.fda.gov/AboutFDA/CentersOffices/Of...384132.htm
(same page i think)
MMTC FOR SURE