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Improving patient access to new medical gadgets by strengthening and streamlining the clinical trial enterprise is a precedence for the FDA. An necessary a part of reaching that goal is to raised monitor milestones in clinical trial growth, Investigational Device Exemption (IDE) approval, examine initiation, and examine completion. The FDA's commitment to reporting sure metrics related to IDE approval may be found in the MDUFA III Commitment Letter to Congress. On August 18, 2013, CDRH up to date the system used to process IDE and Emergency Use Authorization (EUA) submissions. The changes will provide a mechanism for luggage tracking device multiple studies-comparable to feasibility or pivotal research-below a single authentic IDE submission number. Each subsequent submission to an IDE will likely be assigned to the appropriate study, so that the FDA can monitor milestones in clinical trial growth, IDE approval, examine initiation, and study completion. The next changes will influence IDE submissions acquired on or after August 18, 2013. These changes didn't impression the evaluate period for these submissions. |
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