FY 2003 ODE/OIVD Annual Report - Part 7 - Operational Summary - Section 1

Table 3. PMA/HDE/IDE/510(k) Submissions Received
Table 4. Original PMA Decision Cohort Performance
Table 5. Original PMA Receipt Cohort Performance
Table 6. PMA Supplement Decision Cohort Performance
Table 7. PMA Supplement Receipt Cohort Performance
Table 8. PMA Panel Track Supplement Receipt Cohort Performance
Table 9. HDE Submissions Received

 

[NOTE: Although accurate at the time of publication, the data in the following tables may change slightly in subsequent reports to reflect changes in the regulatory status of submissions or verification of data entry. For example, if an incoming PMA supplement is later converted to an original PMA, changes are made in the appropriate tables. Likewise, some data from earlier reporting periods may have been changed to reflect similar corrections in data entry. These adjustments are not likely to have a significant effect on conclusions based on these data. Percentages of actions are presented in some tables. They may not add up to 100% in all cases due to the rounding off of fractions.] Refer to Tables 1 (page 14) and 2 (page 15) for general summary of major submissions received and completed.

 Table 3. PMA/HDE/IDE/510(k) Submissions Received
FY 99 - FY 03

 Table 4. Original PMA Decision Cohort Performance
FY 99- FY 03

a/ Includes actions that did not result in an approval/denial decision, such as GMP deficiency letters prior to inspection, an applicant directed hold, reclassification of the device and conversion of the PMA to another regulatory category, or official correspondence concerning abandonment or withdrawal of the PMA, placing the PMA on hold, and other miscellaneous administrative actions.
b/ Average review times are calculated under the Premarket Approval of Medical Devices Regulation (21 CFR Part 814). Under this regulation, the review clock is reset upon FDA's receipt of a "major amendment" or a response to a "refuse to file" letter. Thus, average review time, unlike average elapsed time, excludes all review times that occurred prior to the latest resetting of the clock.
c/ The average elapsed time includes all increments of time a PMA was under review, including all of the increments of time it was under review by FDA and all increments of time it was on hold, during which time it was being worked on by the manufacturer. Thus the average elapsed time is the average time taken to obtain approval of a PMA from its filing date until it receives final approval.
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 not reflected in the table.
e/ FDA responsible for processing application.
f/ FDA processing of applications officially suspended pending receipt of additional information from the applicant.

 Table 5. Original PMA 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 March 31, 2003 (first 6 months of the fiscal year). The average elapsed time includes all increments of time a PMA was under review, including all of the increments of time it was under review by FDA and all increments of time it was on hold, during which time it was being worked on by the manufacturer. Thus the average elapsed time is the average time taken to obtain approval of a PMA from its filing date until it receives final approval.
a/ The filing decision represents the count of applications with a filing date within the fiscal year as of the cutoff date. For example, a PMA that is considered complete at the time of submission would have a received date equal to the filed date. However, if the agendy refuses to file the PMA, it is considered incomplete and the filed date becomes the date of the amendment that makes the submission complete for filing. Therefore, it is possible that the submission may be received in one fiscal year but not be considered a filed PMA until a subsequent fiscal year. For the purpose of receipt cohort reporting, PMAs are considered "received" based on the filing date rather than the receipt date.
b/ The final action analyses include actions as of the cutoff date for PMAs received within the fiscal year.
c/ Includes only actions that resulted in withdrawal, conversion, and other final action not resulting in approval or denial.
d/ The first action analyses include actions as of the cutoff date for PMAs that were filed within the fiscal year. This measure excludes PMAs with a final action of withdrawal, conversion, or other final actions.
e/ The first action analyses include actions as of the cutoff date for PMAs that were filed within the fiscal year. This measure includes PMAs with any final action including approval, denial, withdrawal, conversion, or other final actions.
f/ The final actions analyses include actions as of the cutoff date for PMAs that were filed within the fiscal year. This measure excludes PMAs with a final action of withdrawal, conversion, or other final action not resulting in approval or denial.
g/ The final actions analyses include actions as of the cutoff date for PMAs that were filed within the fiscal year. This measure includes PMAs with any final action including approval, denial, withdrawal, conversion, or other final actions.
h/ "On Hold" describes the FDA processing of applications officially suspended pending receipt of additional information from the applicant.

 Table 6. PMA Supplement Decision Cohort Performance
FY 99 - FY 03

a/ Filing and not filing decisions are for panel track PMA supplements only. Nonpanel track PMA supplements are automatically filed upon receipt.
b/ Includes actions that did not result in an approval/denial decision, such as GMP letters prior to inspection, an applicant directed hold, reclassification of the device and conversion of the PMA supplement to another regulatory category, and official correspondence concerning the abandonment or withdrawal fo the supplement, the status of the supplement as a special (change being effected) or 30-day submission, and other miscellaneous administrative action.
c/ Panel track supplements are subject to the full administrative procedures normally associated with original PMAs, i.e., panel review, preparation of a summary of safety and effectiveness.
d/ Average review times are calculated under the Premarket Approval of Medical Devices Regulation (21 CFR Part 814). Under this regulation, the review clock is reset upon FDA's receipt of a "major amendment" or a response to a "refuse to file" letter. Thus, average review time, unlike average elapsed time, excludesall review times that occurred prior to the latest resetting of the clock.
e/ The average elapsed time includes all increments of time a PMA was under review, including all of the increments of time it was under review by FDA and all increments of time it was on hold, furing which time it was being worked on by the manufacturer. Thus the average elapsed time is the average time takento obtain approval of a PMA from its filing date until it receives final approval.
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/ FDA responsible for processing application.
h/ FDA processing of applications officially suspended pending receipt of additional information from the applicant.

 Table 7. PMA Supplement 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 March 31, 2003 (first 6 months of the fiscal year). The average elapsed time includes all increments of time a PMA was under review, including all of the increments of time it was under review by FDA and all increments of time it was on hold, during which time it was being worked on by the manufacturer. Thus the average elapsed time is the average time taken to obtain approval of a PMA from its filing date until it receives final approval. Panel Track Supplement times are quantified in Table 8.
a/ The final action analyses include actions as of the cutoff date for PMA supplements received within the fiscal year.
b/ Includes only actions that resulted in withdrawal, conversion, and other final action not resulting in approval or denial.
c/ Filing and not filing decisions are for panel track PMA supplements only. Nonpanel track PMA supplements are automatically filed upon receipt.
d/ The first action analyses includes actions as of the cutoff date for PMAs that were filed within the fiscal year. This measure excludes PMA supplements with a final action of withdrawal, conversion, or other final actions.
e/ The first action analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure includes PMA supplements with any final action including approval, denial, withdrawal, conversion, or other final actions.
f/ The final actions analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure excludes PMA supplements with a final action of withdrawal, conversion, or other final action not resulting in approval or denial.
g/ The final actions analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure includes PMA supplements with any final action including approval, denial, withdrawal, conversion, or other final actions.
h/ "On Hold" describes the FDA processing of applications officially suspended pending receipt of additional information from the applicant.

 Table 8. PMA Panel Track Supplement 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 March 31, 2003 (first 6 months of the fiscal year). The average elapsed time includes all increments of time a PMA was under review, including all of the increments of time it was under review by FDA and all increments of time it was on hold, during which time it was being worked on by the manufacturer. Thus the average elapsed time is the average time taken to obtain approval of a PMA from its filing date until it receives final approval.
a/ Filing and not filing decisions are for panel track PMA supplements only. Nonpanel track PMA supplements are automatically filed upon receipt.
b/ The final action analyses include actions as of the cutoff date for PMA supplements received within the fiscal year.
c/ Includes only actions that resulted in withdrawal, conversion, and other final action not resulting in approval or denial.
d/ The first action analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure excludes PMA supplements with a final action of withdrawal, conversion, or other final actions.
e/ The first action analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure includes PMA supplements with any final action including approval, denial, withdrawal, conversion, or other final actions.
f/ The final actions analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure excludes PMA supplements with a final action of withdrawal, conversion, or other final action not resulting in approval or denial.
g/ The final actions analyses include actions as of the cutoff date for PMA supplements that were filed within the fiscal year. This measure includes PMA supplements with any final action including approval, denial, withdrawal, conversion, or other final actions.
h/ "On Hold" describes the FDA processing of applications officially suspended pending receipt of additional information from the applicant.

 Table 9. HDE Submissions Received
FY 99 – FY 03