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In FY 2005, FDA categorized 273 original applications under review as combination products. The table below reflects the number of original applications classified into one of nine combination product categories for original NDAs, BLAs, PMAs, 510(k)s, INDs, IDEs, and HDEs.
Number and Types of Combination Products |
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|---|---|---|---|---|---|---|---|---|---|---|---|
Application Type |
Combination Product Category |
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1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
TOTALS |
||
Original NDAs |
2 |
9 |
-- |
-- |
-- |
-- |
1 |
-- |
-- |
12 |
|
Original BLAs |
1 |
-- |
1 |
-- |
-- |
-- |
-- |
-- |
-- |
2 |
|
Original PMAs |
-- |
-- |
-- |
2 |
-- |
-- |
-- |
-- |
-- |
2 |
|
Original 510(k)s |
5 |
-- |
-- |
55 |
8 |
-- |
4 |
-- |
3 |
75 |
|
Original INDs |
2 |
48 |
12 |
3 |
5 |
12 |
17 |
56 |
1 |
156 |
|
Original IDEs |
1 |
-- |
-- |
18 |
5 |
-- |
1 |
1 |
-- |
26 |
|
Original HDEs |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
|
TOTALS |
11 |
57 |
13 |
78 |
18 |
12 |
23 |
57 |
4 |
273 |
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COMBINATION PRODUCT KEY: |
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Of the 273 original combination product applications, CBER received and categorized as combination products 31 applications; CDER received and categorized as combination products 139 applications; and CDRH categorized 103 applications, which were reviewed and acted on as of September 30, 2006.