Medical Device User Fees Hearing Before the Subcommittee On Health And the Env
Medical Device User Fees Hearing Before the Subcommittee On Health And the Env
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To quickly assess the difficulty of the text, read a short excerpt:
The backlog is defined as the number of applications overdue (i. E. , under review for longer than the statutory time frame - - 90 days for 510(k) 's and 180 days for PMA's/PLA's) . Therefore, no later than 24 months after the effective date of the progrzua, not more than 5 percent of the pending 510 (k) applications may be overdue.
For example, if the program's effective date is October 1, 1994, and if 2, 000 510 (k) applications are pending on September 30, 1996, not more than 100 510(k) appl...ications (2000 x . 05) can be overdue at that time. Similarly, if 100 PMA's are pending on September 30, 1996, not more than 10 PMA's (100 x . 10) can be overdue at that time.
Long-term Qoala for Applications Submitted Beginning in the 25th Month After the Effective Date of the Program 1. FDA will complete final action on 95 percent of premarket notifications (510(k) 's) within 90 days.
2. FDA will complete a comprehensive, substantive review on 90 percent of the PMA's and PLA's within 180 days.
What to read after Medical Device User Fees Hearing Before the Subcommittee On Health And the Env?
You can find similar books in the "Read Also" column, or choose other free books by Ze20a20device20application20fee2c20and20for to read onlineMoreLess
To quickly assess the difficulty of the text, read a short excerpt:
The backlog is defined as the number of applications overdue (i. E. , under review for longer than the statutory time frame - - 90 days for 510(k) 's and 180 days for PMA's/PLA's) . Therefore, no later than 24 months after the effective date of the progrzua, not more than 5 percent of the pending 510 (k) applications may be overdue.
For example, if the program's effective date is October 1, 1994, and if 2, 000 510 (k) applications are pending on September 30, 1996, not more than 100 510(k) appl...ications (2000 x . 05) can be overdue at that time. Similarly, if 100 PMA's are pending on September 30, 1996, not more than 10 PMA's (100 x . 10) can be overdue at that time.
Long-term Qoala for Applications Submitted Beginning in the 25th Month After the Effective Date of the Program 1. FDA will complete final action on 95 percent of premarket notifications (510(k) 's) within 90 days.
2. FDA will complete a comprehensive, substantive review on 90 percent of the PMA's and PLA's within 180 days.
What to read after Medical Device User Fees Hearing Before the Subcommittee On Health And the Env?
You can find similar books in the "Read Also" column, or choose other free books by Ze20a20device20application20fee2c20and20for to read onlineMoreLess
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