FY 2003 ODE/OIVD Annual Report - Part 7 - Operational Summary - Section 2

Table 10. Original HDE Decision Cohort Performance
Table 11. HDE Supplement Decision Cohort Performance
Table 12. Original IDEs
Table 13. IDE Amendments
Table 14. IDE Supplements
Table 15. 510(k) Decision Cohort Performance
Table 16. 510(k) Receipt Cohort Performance

 Table 10. Original HDE Decision Cohort Performance
FY 99 – FY 03

a/ Includes interim action, placing a file on hold, such as jurisdiction issue, and final actions, such as withdrawal or conversion to another regulatory category, that occur prior to a filing decision being made.
b/ Includes actions that did not result in a final decision, such as GMP deficiency letter or an applicant-directed hold.
c/ Includes final actions other than approval or denial, such as withdrawal, abandonment warning letter or conversions to another regulatory category.
d/ First actions may include major and minor deficiency decisions; approvable, not approvable, approval and denial decisions; receipt of an unsolicted major amendment; and other final actions, such as withdrawal or conversion to another regulatory category.
e/ The average amount of time taken to obtain approval of an HDE from the filing date until final approval.
f/ A cycle is counted as the intial submission and each resetting of FDA's review clock, such as a response to a non-filing decision or the submission of a major amendment.
g/ The number under review at the end of a period may not reconcile with the number under review at the end of the previous period (plus receipts less approvals) because of deletions and conversions not reflected in the table.
h/ The application is under review by FDA.
i/ FDA's review of the application is officially suspended pending receipt of additional information from the applicant.

 Table 11. HDE Supplement Decision Cohort Performance
FY 99 – FY 03

a/ Includes actons that did not result in a final decision, such as GMP deficiency letter, an applicant-directed hold, official correspondence concerning the status of the supplement or other miscellaneous administrative action.
b/ Includes final actions other than approval or denial, such as withdrawal or conversion to another regulatory category.
c/ First actions may include major and minor deficiency decisions; approvable, not approvable, approval and denial decisions; receipt of an unsolicited major amendment; and other final actions, such as withdrawal or conversion to another regulatory category.
d/ The average amount of time taken to obtain approval of an HDE Supplement from the filing date until final approval.
e/ A cycle is counted as the initial submission and each resetting of FDA's review clock, such as a response to a non-filing decision or the submission of a major amendment.
f/ The number under review at the end of a period may not reconcile with the number under review at the end of the previous period (plus receipts less approvals) because of deletions and conversions which are not reflected in the table.
g/ The application is under review by FDA.
h/ FDA 's review of the application is officially suspended pending receipt of additional information from the applicant.

 Table 12. Original IDEs
FY 99 - FY 03

a/ Includes deletions, withdrawals, and other administrative actions not resulting in an approval/disapproval decision.
b/ Based on "approved" and "not approved" decisions only.
c/ The number under review at the end of a period may not reconcile with the number under review at the end of the previous period (plus receipts lessapprovals) because of deletions and conversions which are not reflected in the table.

 Table 13. IDE Amendments
FY 99 - FY 03

a/ Submissions received after the original IDE and prior to approval of the IDE application.
b/ Includes actions that did not result in an approval/disapproval decision, such as withdrawal of the IDE or the amendment by the sponsor, and other administrative actions, e.g., acknowledgement letters concerning the submission of information that did not require independent approval/disapproval and other administrative information, such as a change of address.
c/ The average IDE approval time represents the total time it has taken, on average, for an original IDE that was initially disapproved to be approved after the submission of amendments to correct deficiencies. The time being measured here covers the period from the date the original IDE was received to the date of final approval of an IDE amendment.
d/ The number under review at the end of a period may not reconcile with the number under review at the end of the previous period (plus receipts less approvals) because of deletions and conversions which are not reflected in the table.

 Table 14. IDE Supplements
FY 99 - FY 03

a/ The number under review at the end of a period may not reconcile with the number under review at the end of the previous period (plus receipts less approvals) because of deletions and conversions which are not reflected in the table.

 Table 15. 510(k) Decision Cohort Performance
FY 99 - FY 03

a/ Includes final administrative actions that did not result in a substantially equivalent/not substantially equivalent decision because of the 510(k) or device/product was withdrawn by the applicant, deleted due to lack of response, a duplicate, not a device, a transitional device, regulated by CBER, a general purpose article, exempted by regulation, and other miscellaneous action.
b/ Based on "substantially equivalent" and "not substantially equivalent" decisions only.
c/ FDA time includes all increments of time FDA reviewed a 510(k), so long as the 510(k) document number did not change; changes in 510(k) document numbers occur rarely.
d/ Includes all time from receipt to final decision, i.e., does not exclude time a submission is on hold pending receipt of additional information.
e/ Considers whether FDA review time remained within 90 days, with FDA's review clock being reset to zero whenever additonal information was received (in accordance with 21 CFR 807.87(l)).
f/ The number under review at the end of a period may not reconcile with the number under review at the end of the previous period (plus receipts less decisions) because of deletions and conversions which are not reflected in the table.
g/ FDA responsible for processing notification.
h/ FDA's processing of notification officially suspended pending receipt of additional information from the submitter.

 Table 16. 510(k) Receipt Cohort Performance*
FY 99 - FY 03

*/ For each fiscal year, September 30, 2003 was used as the cutoff date. The FY03 cohort represents only receipts through June 30, 2003 (first nine months of the fiscal year).
a/ Includes Third Party 510(k)s: FY99 = 32; FY00 = 47; FY01 =107; FY02 = 127; FY03 = 126 (9 months)
b/ Based on “substantially equivalent” and “not substantially equivalent” decisions only.
c/ Includes final administrative actions that did not result in a substantially equivalent/not substantially equivalent decision because the 510(k) or device/product was: withdrawn by the applicant, deleted due to lack of response, a duplicate, not a device, a transitional device, regulated by CBER, a general purpose article, exempted by regulation, and other miscellaneous actions.
d/ FDA time includes all increments of time FDA reviewed a 510(k), so long as the 510(k) document number did not change; changes in 510(k) document numbers occur rarely.
e/ Includes all time from receipt to final decision, i.e., does not exclude time a submission is on hold pending receipt of additional information