Percent of Office of In Vitro Diagnostics and Radiological Health (OIR) 510(k) decisions meeting MDUFA goals during the month
Dictionary: The Medical Device User Fee Amendments (MDUFA II) require FDA to pursue a comprehensive set of device review performance goals, intended to significantly improve the timeliness and predictability of FDA’s review of new devices. MDUFA II performance goals are measured by receipt cohort. By using the decision cohort, this measure provides a different approach to monitoring MDUFA related 510(k) performance goals. The measure tracks the number of 510(k) decisions made during the month that were within 90 FDA days. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to a Premarket Approval (PMA).
Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency (SE) claims. A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found SE through the 510(k) process. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate.
Information is current as of September 30, 2013
Fiscal Year - 2013
FY 2013 Overall: 96%
Number of OIR 510(k) decisions made in 90 days or less during the month
Fiscal Year - 2013
FY 2013 Total: 684
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.