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|English to Japanese translations [PRO]|
Medical - Medical (general)
|English term or phrase: panel-track and 180-day user-fee supplements|
|We obtained and analyzed data on submissions for which FDA made review decisions in fiscal years 2003 through 2007.13 Our analysis included traditional and abbreviated 510(k) submissions, original PMA submissions, and submissions for certain types of PMA supplements (panel-track and 180-day user-fee supplements).|
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|Reference: 180-Day Supplements|
2. 180-Day Supplements
Under section 737(4)(C) of the Act, which was added by section 102 of MDUFMA, a "180-day supplement" is defined as:
"a supplement to an approved premarket application or premarket report under section 515 that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling." (21 U.S.C. 379i(4)(C))
Read in conjunction with section 515(d)(6) of the Act, this language means that submission of a 180-Day Supplement is required for certain types of significant changes to the approved device that affect safety and effectiveness of the device. In general, in order for a change to be submitted as a 180-Day Supplement, the clinical data provided in support of the original device approval should still be applicable in supporting the approval of the modified device. In most cases, for such modifications, only new pre-clinical testing is needed to demonstrate reasonable assurance of safety and effectiveness of the modified device. In some instances, however, additional limited confirmatory clinical data may be necessary to provide a bridge between the clinical data set for the original device and the expected clinical performance of the modified device. Although additional clinical data may be necessary, the data collected are usually from a limited number of patients. Changes to devices that may require a 180-Day Supplement include:
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Native speaker of: Japanese
PRO pts in category: 313
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