Regulatory Open Forum

FDA operates against two 510(k) review clocks:  One for the acceptance review phase, and one for the substantive review phase.  These clocks are not necessarily concurrent; instead, they may run in series/succession depending on the outcome of the acceptance review.

The acceptance review clock duration is 15 calendar days for each acceptance review.  In other words, FDA has 15 calendar days after receipt of the 510(k) by the DCC (Document Control Center) in which to complete an acceptance review against FDA's RTA criteria.  If acceptance review deficiencies are found, then FDA, as a general rule, issues a Refuse to Accept (RTA).  When that happens, the Sponsor has up to 180 days to respond to the RTA.  Once FDA receives the Sponsor's RTA response, FDA has another 15-calendar day acceptance review clock in which to review the RTA corrections.

Only once the submission has passed the acceptance review criteria (i.e., been accepted for substantive review) can the the 30-day Special 510(k) review clock (or 90-day Traditional or Abbreviated review clock) be calculated.  The substantive review clock is calculated starting from the DCC receipt date of the most recent acceptance submission that ultimately allowed the submission to be accepted for substantive review.

Hope this helps.

FDA operates against two 510(k) review clocks:  One for the acceptance review phase, and one for the substantive review phase.  These clocks may or may not run concurrently depending on the outcome of the acceptance review.

The acceptance review clock duration is 15 calendar days for each acceptance review.  In other words, FDA has 15 calendar days after receipt of the 510(k) by the DCC (Document Control Center) in which to complete an acceptance review against FDA's RTA criteria.  If acceptance review deficiencies are found, then FDA, as a general rule, issues a Refuse to Accept (RTA).  When that happens, the Sponsor has up to 180 days to respond to the RTA.  Once FDA receives the Sponsor's RTA response, FDA has another 15-calendar day acceptance review clock in which to review the RTA corrections.

Only once the submission has passed the acceptance review criteria (i.e., been accepted for substantive review) can the the 30-day Special 510(k) substantive review clock (or 90-day Traditional or Abbreviated substantive review clocks) be calculated.  The substantive review clock is calculated starting from the DCC receipt date of the most recent submission that ultimately allowed the submission to be accepted for substantive review.

So this means that if the RTA response which finally allows FDA to accept the 510(k) for substantive review was received by the DCC on calendar day 22, then the overall MDUFA performance goal clock is calculated starting from that day 22.  In other words, FDA's MDUFA performance goal will be 30 days after day 22 (i.e., day 52) for a Special 510(k), or 90 days after day 22 (i.e., day 112) for a Traditional or Abbreviated 510(k).

FDA operates against two 510(k) review clocks:  One for the acceptance review phase, and one for the substantive review phase.  These clocks may or may not run concurrently depending on the outcome of the acceptance review.

The acceptance review clock duration is 15 calendar days for each acceptance review.  In other words, FDA has 15 calendar days after receipt of the 510(k) by the DCC (Document Control Center) in which to complete an acceptance review against FDA's RTA criteria.  If acceptance review deficiencies are found, then FDA, as a general rule, issues a Refuse to Accept (RTA).  When that happens, the Sponsor has up to 180 days to respond to the RTA.  Once FDA receives the Sponsor's RTA response, FDA has another 15-calendar day acceptance review clock in which to review the RTA corrections.

Only once the submission has passed the acceptance review criteria (i.e., been accepted for substantive review) can the the 30-day Special 510(k) substantive review clock (or 90-day Traditional or Abbreviated substantive review clocks) be calculated.  The substantive review clock is calculated starting from the DCC receipt date of the most recent submission that ultimately allowed the submission to be accepted for substantive review.

So this means that if the RTA response which finally allows FDA to accept the 510(k) for substantive review was received by the DCC on calendar day 22, then the overall MDUFA performance goal clock is calculated starting from that day 22.  In other words, FDA's MDUFA performance goal will be 30 days after day 22 (i.e., day 52) for a Special 510(k), or 90 days after day 22 (i.e., day 112) for a Traditional or Abbreviated 510(k).

Hello-at FDA the 510(k) deadlines definitely were "deadlines" that, if missed, knocked a division's performance statistics.

At least when I was there, the 15 day RTA deadline was a true deadline-if an RTA decision was not made by FDA day 15, the decision was automatically RTAA, a letter was automatically sent out, and the branch chief (now called "Assistant Director") got upset.

As a reviewer I had up to 14 510(k)'s on my desk at a time.  The amount of time I took to make an RTA decision depended much more on when I actually got around to opening a file than what was in the file.

As an interesting side note, when RTA was initially rolled out, a lot of submissions got rejected over stupid issues, like condom manufacturers not having provided adequate software documentation with a submission.

At that point, the RTA criteria were made much tighter.

Hello-at FDA the 510(k) deadlines definitely were "deadlines" that, if missed, knocked a division's performance statistics.

At least when I was there, the 15 day RTA deadline was a true deadline-if an RTA decision was not made by FDA day 15, the decision was automatically RTAA, a letter was automatically sent out, and the branch chief (now called "Assistant Director") got upset.

As a reviewer I had up to 14 510(k)'s on my desk at a time.  The amount of time I took to make an RTA decision depended much more on when I actually got around to opening a file than what was in the file.

As an interesting side note, when RTA was initially rolled out, a lot of submissions got rejected over stupid issues, like condom manufacturers not having provided adequate software documentation with a submission.

At that point, the RTA criteria were made much tighter.

Hello-at FDA the 510(k) deadlines definitely were "deadlines" that, if missed, knocked a division's performance statistics.

At least when I was there, the 15 day RTA deadline was a true deadline-if an RTA decision was not made by FDA day 15, the decision was automatically RTAA, a letter was automatically sent out, and the branch chief (now called "Assistant Director") got upset.

As a reviewer I had up to 14 510(k)'s on my desk at a time.  The amount of time I took to make an RTA decision depended much more on when I actually got around to opening a file than what was in the file.

As an interesting side note, when RTA was initially rolled out, a lot of submissions got rejected over stupid issues, like condom manufacturers not having provided adequate software documentation with a submission.

At that point, the RTA criteria were made much tighter.