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FY 2000 ODE Annual Report - Part 5 – 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. HDE Submissions Received FY97 – FY00
Table 9. Original HDE Decision Cohort Performance FY97 – FY00

[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. There are also likely to be changes in the previous years’ annual report numbers in tables representing receipt cohort data. 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 96 - FY 00

Type of Submission Number Received
 

FY 96

FY 97

FY 98

FY 99

FY 00


Premarket Approval (PMAs)
         
  Original Applications 44 66 47 60 67
  Amendments 883 829 710 767 978
  Supplements 415 409 513 552 545
  Amendments to Supplements 823 819 863 924 932
  Reports for Orig. Applications 435 435 431 406 419
  Reports for Supplements 24 2 0 0 0
  Master Files 65 130 94 25 44
  PMA Subtotal 2,689 2,690 2,658 2,734 2,985

         
Humanitarian Device Exemptions (HDEs)          
  Original Applications 0 4 8 12 11
  Amendments 0 10 32 55 56
  Supplements 0 0 0 4 10
  Amendments to Supplements 0 0 0 3 12
  Reports for Orig. Applications 0 0 0 6 9
  Reports for Supplements 0 0 0 0 0
  HDE Subtotal 0 14 40 80 98

         
Investigational Device Exemptions (IDEs)          
  Original Applications 253 297 322 304 311
  Amendments 219 223 226 275 240
  Supplements 3,189 3,776 4,277 4,127 4,388
  IDE Subtotal 3,661 4,296 4,825 4,706 4,939

         
Premarket Notification (510(k)s)          
  Original Notifications 5,297 5,049 4,623 4,458 4,202
  Supplements 3,246 2,785 2,023 1,872 1,742
  Amendments 5,343 4,433 3,692 2,962 2,953
  510(k) Subtotal 13,886 12,267 10,338 9,292 8,897

         
PMA/HDE/IDE/510(k) Total 20,236 19,267 17,861 16,812 16,919

 

Table 4. Original PMA Decision Cohort Performance*
FY 96 - FY 00

 

FY 96

FY 97

FY 98

FY 99

FY 00


Number Received

44

0

55

72

67

         
PMA Actions Filing Decisions          
  Filed 45 58 51 65 64
  Not Filed 17 16 10 7 4
  Others 0 0 0 0 0
    Filing Decision Subtotal 62 74 61 72 68
Scientific Review Decisions          
  Major Deficiencies 32 38 28 32 51
  Minor Deficiencies 5 5 10 4 11
  Othera 97 138 105 105 111
    Scientific Review Decisions Subtotal 134 181 143 141 173
Approval Decisions          
  Approvals 43 48 46 45 43
  Approvable    27 14 7 7 33
  Not Approvable 6 5 12 1 4
  Denials 0 0 0 0 0
    Approval Decision Subtotal   76   67   65   53   80
Total PMA Actions 272 322 269 266 321

         
Average Review Time (Days)          
  for Approvalsb          
    FDA 289 207 154 149 158
   Non-FDA   55   40   37   26   40
    Total 343 247 191 175 198

         
Average Elapsed Time (Days)          
  for Approvalsc          
    FDA 572 375 265 280 244
   Non-FDA 214 122 108 100 119
    Total 786 497 373 380 363

         
Number under Review at End of Periodd          
  Activee 57 44 29 49 35
  (Active and overdue) (17) (0) (0) (0) (0)
  On holdf 39 41 41 38 41
  Total 96 85 70 87 76
_____________________
*/ For FY 97, 98 and 99, PMA data includes a special category of PMAs. Humanitarian Devices Exemption (HDE) applications are similar in both form and content to PMAs but are exempt from the effectiveness requirements of PMAs. An approved HDE authorizes marketing of the humanitarian use device.
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 the 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. Number of months based upon 30.4 day/month and rounded to one decimal point.
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 96 – FY 00

 

FY 96

FY 97

FY 98

FY 99

FY 00


Original PMAs Received
                   
  PMAs

37

  46   32   48   42  
  Expedited PMAs   5   10     6     7     4  
  Total 42   56   38   55   46  

                   
Filing Decisionsa                    
  Filed 42   56   38   55   46  
  Not Filed 11   8   3   1   2  
  Number (%) of Filing/Not Filing                    
    Decisions within 45 Days 26 (49) 51 (80) 30 (73) 44 (79) 39 (81)
  Average Days/Cycle 67   39   44   42   40  

                   
Final Actionsb                    
  Approvals 28   45   26   38   12  
  Denials 0   0   0   0   0  
Otherc 18   22   15     9     8  
  Total 46   67   41   47   20  

                   
Filing to First Action Excluding withdrawals, conversions, etc.d
  Number Received and Filed 42   56   38   55   46  
  Number of First Actions 37   53   37   55   41  
  Average FDA Days 195   147   134   145   139  
  Median FDA Days 187   175   145   147   160  
  Number (%) of First Actions
    within 180 Days

18

(43)

41

(73)

32

(84)

43

(78)

41

(89)

                   
Filing to First Action Including withdrawals, conversions, etc.e
  Number Received and Filed 42   56   38   55   46  
  Number of First Actions 42   56   38   55   46  
  Average FDA Days 228   146   134   145   140  
  Median FDA Days 183   173   141   147   152  
  Number (%) of First Actions
    within 180  Days

20

(48)

43

(77)

33

(87)

43

(78)

46

(100)

                   
Filing to Final Actions Excluding withdrawals, conversions, etc.f
  Number Received and Filed 42   56   38   55   46  
  Number of Final Actions 30   45   28   35   15  
  Average FDA (Total) Elapsed
    Time

358

(514)

264

(346)

239

(321)

244

(293)

164

(214)
  Median FDA (Total) Elapsed
    Time

329

(408)

217

(287)

198

(201)

240

(269)

178

(211)
  Number (%) of Final Actions
    within 180 FDA Days

6

(20)

19

(42)

12

(43)

7

(20)

11

(73)
  Number (%) of Final Actions
    within 180 Total Days

4

(13)

16

(36)

10

(36)

5

(14)

5

(33)

                   
Filing to Final Action Including withdrawals, conversions, etc.g
  Number Received and Filed 42   56   38   55   46  
  Number of Final Actions 42   54   34   38   23  
  Average FDA (Total) Elapsed
    Time

378

(530)

257

(373)

224

(355)

245

(303)

161

(200)
  Median FDA (Total) Elapsed Time 321 (420) 200 (315) 187 (252) 243 (271) 175 (195)
  Number (%) of Final Actions
    within 180 FDA Days

8

(19)

23

(43)

17

(50)

8

(21)

18

(78)
  Number (%) of Final Actions
    within 180 Total Days

6

(14)

18

(33)

11

(32)

5

(13)

10

(44)
 
  Average Number of FDA Cycles
    from Receipt to Final Action
    Including
                   
 
  Withdrawals, conversions, etc b.


1.9

 


1.7

 


1.7

 


1.8

 


1.3

 

                   
Percentile FDA Days from Filing to First Actione
  25th 165   111   99   115   113  
  50th (Median) 183   173   141   147   152  
  75th 231   180   174   179   176  
  90th 316   199   181   227   179  

                   
Percentile FDA Days from Filing to First Actiond
  25th 171   118   99   115   116  
  50th (Median) 187   175   145   147   160  
  75th 252   182   175   179   179  
  90th --   217   192   227   --  

                   
Percentile FDA (Total) Days from Filing to Final Actiong
  25th 233 (272) 165 (177) 141 (158) 185 (236) 120 (175)
  50th (Median) 321 (420) 200 (315) 187 (252) 243 (271) 175 (195)
  75th 432 (785) 382 (520) 289 (564) 284 (384) 181 (234)
  90th 712 (961) 440 (708) 392 (789) 341 (481) 202 (280)

                   
Percentile FDA (Total) Days from Filing to Final Actionf
  25th 233 (272) 170 (177) 157 (158) 185 (234) 147 (178)
  50th (Median) 329 (408) 217 (287) 198 (201) 240 (269) 178 (211)
  75th 419 (779) 390 (520) 328 (387) 284 (372) 181 (240)
  90th 710 (987) 440 (680) 392 (801) 341 (437) 228 (280)

                   
Number pending as of 9/30/00                    
  Active    0   1   0   8   8  
  Active and Overdue 0   0   0   0   0  
  On holdh 0   1   7   9   16  
  Total 0   2   7   17   24  

                   
Summary of PMA Receipt Cohort                    
  Approved 28   45   26   38   12  
  Denied 0   0   0   0   0  
  Withdrawn 11   11   9   3   6  
  Other 7   11   6   6   2  
  Under Review 0   1   0   8   8  
  On Holdh   0     1     7     9   16  
  Total     46   69   48   64   44  
                     
_____________________
*/ For each fiscal year, September 30, 2000 was used as the cutoff date. The FY 00 cohort represents only receipts through March 31, 2000 (first six 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 agency 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 actions 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 96 - FY 00

 

FY 96

FY 97

FY 98

FY 99

FY 00


Number Received

415

409

513

556

545

         

PMA Supplement Actions

Panel Track Filing Decisionsa

         
  Filed 8 15 7 17 14
  Not Filed 1 1 2 2 3
  Other 0 0 0 0 0
    Filing Decision Subtotal 9 16 9 19 17
Scientific Review Decisions          
  Major Deficiencies 9 3 4 12 14
  Minor Deficiencies 1 1 2 0 1
  Otherb 141 128 62 60 83
    Scientific Review Decisions Subtotal 151 132 68 72 98
Approval Decisions          
  Panel track approvalsc 0 4 5 11 12
  Nonpanel track approvals 462 397 416 426 462
  Approvable 33 49 47 25 100
  Not approvable 48 76 63 62 58
    Approval Decision Subtotal 543 526 531 524 632
  Total PMA Supplement Actions     703 674 608 615 747

         
Average Review Time (Days) for Approvalsd          
  FDA 146 100 82 76 76
  Non-FDA 36 12 25 16 18
  Total 182 112 107 92 94

         
Average Elapsed Time (Days) for Approvalse          
  FDA 167 120 109 92 95
  Non-FDA   49   23   43   26   27
  Total 216 143 153 118 122

         
Number under Review at End of Periodf          
  Activeg 162 110 139 158 98
  (Active and overdue) (17) (0) (0) (0) (0)
  On holdh   74   80   57 70 84
  Total     236 190 196 228 182
           
_________________
*/ For FY 97, 98 and 99, PMA data includes a special category of PMAs. Humanitarian Devices Exemption (HDE) applications are similar in both form and content to PMAs but are exempt from the effectiveness requirements of PMAs. An approved HDE authorizes marketing of the humanitarian use device.
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 of the supplement, the status of the supplement as a special (changes being effected) or 30-day submission, and other miscellaneous administrative actions.
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, excludes all review times that occurred prior to the latest resetting of the clock. Number of months based upon 30.4 day/month and rounded to one decimal point.
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, 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.
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’s processing of application officially suspended pending receipt of additional information from the applicant.

Table 7. PMA Supplement Receipt Cohort Performance*
FY 96 - FY 00

 

FY 96

FY 97

FY 98

FY 99

FY 00


PMA Supplements Received
                   
  PMA Supplements 410   402   510   541   270  
  Expedited PMA Supplements    3      3      1      6      1  
  Total 413   405   511   547   271  

                   
Filing Decisionsa                    
  Filed 4   6   9   15   7  
  Not Filed 0   1   1   0   1  
  Number of Filing/Not Filing                    
    Decisions within 45 Days 3   5   9   10   7  
  Average Days/Cycle 45   45   42   45   43  

                   
PMA Supplement Final Actionsb                    
  Approvals 379   369   427   441   200  
  Denials 0   0   0   0   0  
  Otherc      34   36   82   84   47  

                   
Filing to First Action Excluding withdrawals, conversions, etc.d
  Number Received and Filed 413   405   511   547   271  
  Number of First Actions 398   396   491   526   265  
  Average 122   90   82   74   67  
  Median 130   73   59   39   42  
  Number (%) of First Actions
    within 180 Days

311

(75)

350

(86)

433

(87)

475

(87)

262

(97)

                   
Filing to First Action Including withdrawals, conversions, etc.e

                   
  Number Received and Filed      413   405   511   547   271  
  Number of First Actions      411   405   509   544   271  
  Average     121   91   80   74   67  
  Median     126   70   49   37   39  
  Number (%) of First Actions
    within 180 Days
322 (78) 357 (88) 460 (90) 49 1(90) 268 (99)
  Average Number of FDA Cycles
    from Receipt to Final Action
    Including
                   
  withdrawals, conversions, etc.b 1.2   1.1   1.1   1.1   1.0  

                   
Filing to Final Action Excluding withdrawals, conversions, etc.f
  Number Received and Filed      413   405   511   547   271  
  Number of Final Actions      379   367   460   486   240  
  Average FDA (Total) Review
    Days
148 (185) 106 (129) 94 (118) 79 (95) 66 (76)
  Median FDA (Total) Review
    Days
132 (150) 70 (83) 49 (66) 35 (47) 35 (43)
  Number (%) of Final Actions
    Within 180 Days

259

(68)

304

(83)

374

(81)

420

(86)

234

(98)
  Number (%) of Final Actions
    Within 180 Total Days

236

(62)

286

(78)

352

(77)

406

(84)

225

(94)

                   
Filing to Final Action Including withdrawals, conversions, etc.g
  Number Received and Filed 413   405   511   547   271  
  Number of Final Actions 413   400   503   517   247  
  Average FDA (Total) Review
    Days
147 (202) 110 (147) 97 (131) 82 (102) 66 (75)
  Median FDA (Total) Review
    Days
132 (156) 74 (94) 51 (69) 36 (50) 35 (43)
  Number (%) of Final Actions
    Within 180 Days

284

(69)

324

(81)

490

(97)

447

(87)

241

(98)
  Number (%) of Final Actions
    Within 180 Total Days

249

(60)

296

(74)

371

(74)

424

(82)

232

(94)

                   
Percentile FDA Days from Filing to First Actione
  25th 57   29   22   19   20  
  50th (Median) 126   70   49   37   39  
  75th     179   155   156   140   113  
  90th     196   181   180   181   165  

                   
Percentile FDA Days from Filing to First Actiond
  25th 63   32   22   20   21  
  50th (Median) 130   73   59   39   42  
  75th 180   165   169   151   116  
  90th 201   182   183   190   190  

                   
Percentile FDA (Total) Days from Filing to Final Actiong
  25th 63 (76) 33 (36) 22 (24) 20 (24) 18 (24)
  50th (Median) 132 (156) 74 (94) 51 (69) 36 (50) 35 (43)
  75th 187 (225) 169 (182) 175 (182) 147 (161) 109 (118)
  90th 296 (446) 216 (351) 212 (322) 190 (232) 165 (172)

                   
Percentile FDA (Total) Days from Filing to Final Actionf
  25th 64 (76) 32 (35) 22 (25) 19 (24) 18 (24)
  50th (Median)      132 (150) 70 (83) 49 (66) 35 (47) 35 (43)
  75th     187 (210) 162 (179) 175 (179) 141 (152) 108 (117)
  90th     303 (379) 207 (313) 213 (281) 190 (214) 165 (174)

                   
Number under review as of 9/30/00                
  Active     0   0   0   5   4  
  Active and Overdue      0   0   0   2   0  
  On holdh 0   5   8   25   20  
  Total 0   5   8   32   24  

                   
Summary of PMA Supplement Receipt Cohort
  Approved 379   369   427   441   200  
  Denied 0   0   0   0   0  
  Withdrawn 28   28   30   32   6  
  Other 6   8   52   52   41  
  Under Review 0   0   0   7   4  
  On Holdh    0      5      8     25     20  
  Total 413   410   517   557   271  
                     
_____________________
*/ For each fiscal year, September 30, 2000 was used as the cutoff date. The FY 00 cohort represents only receipts through March 31, 2000 (first six 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 as 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 actions 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 8. HDE Submissions Received
FY97 – FY00

Type of Submission

Number Received

 

FY 97

FY 98

FY 99

FY 00


Humanitarian Device
       
  Exemption (HDE)        
  Original Applications

4

8

12

11

  Amendments

10

32

55

56

  Supplements

0

0

4

10

  Amendments to Supplements

0

0

3

12

  Reports for Orig. Applications

0

0

6

9

  Reports for Supplements

    0

     0

     0

    0

         
HDE Subtotal

14

40

80

98

         

Table 9. Original HDE Decision Cohort Performance
FY97 – FY00

 

FY 97

FY 98

FY 99

FY 00


Number Received

4

8

12

11
HDE Actions        
Filing Decisions        
  Filed 2 9 10 8
  Not Filed 0 1 1 4
  Othera 0 1 1 0
    Filing Decision Subtotal 2 11 12 12

       
Scientific Review Decisions        
  Major Deficiencies 0 0 6 7
  Minor Deficiencies 1 1 0 3
  Otherb 0 0 4 6
    Scientific Review Decisions Subtotal 1 1 10 16

       
Approval Decisions        
  Approvals 2 4 6 6
  Approvable 0 0 5 1
  Not Approvable 0 0 0 0
  Denials 0 0 0 0
    Approval Decision Subtotal 2 4 11 7
  Other Final Decisionsc 0   2   4   1
  Total HDE Actions 5 18 37 36

       
Filing to First Actiond        
  Number of First Actions 2 6 13 8
  Average Number of FDA Days

68

139

87

61

  Number of First Actions
    Within 75 Days

1

1

7

8


       
Average Elapsed Time (Days) for Approvalse        
  FDA

108

152

113

112

  Non-FDA

  12

    0

  50

104

  Total

120

152

163

216

 
       
Average Number of FDA Cycles from Receipt to Final Actionf

1

1.2

1.2

1.3


Number under Review at End of Period
       
  Active

2

3

2

2

         
  Active and overdue

0

0

0

0

  On hold

0

1

  8

  8

  Total

2

4

10

10

         
_________________
a/ Includes 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 or conversion to another regulatory category.
d/ 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.
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 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.
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.