The Food & Drug Administration department charged with evaluating medical devices issued its annual performance review for 2009, showing a slight uptick in overall submissions.
The Office of Device Evaluation’s report reveals that total submissions increased 0.6 percent from 2008 to 2009.
The report (PDF) also shows a sharp drop in PMA applications and a 7 percent increase in 510(k) submissions, from 3,363 in 2008 to 3,597 in 2009. Original PMA submissions went from 26 in 2008 to 20 in 2009, a 23 percent decline, while PMA supplements slipped 3.7 percent, from 1,448 in 2008 to 1,394 last year:
510(k)s 1999 – 2009
PMAs 1999 – 2009
The vast majority of 510(k) submissions — 77.7 percent — were filed as "traditional" applications, according to the report, with 18.6 percent filed as "special" and 3.7 percent filed as "abbreviated."
Created under the FDA Modernization Act of 1997, the special 510(k) allows device makers to submit results from the design control process for already-cleared devices that are being modified "if the modification does not affect the intended use of the device or alter the fundamental scientific technology of the device," according to FDA guidelines. The abbreviated application can be used when "(1) a guidance document exists, (2) a special control has been established, or (3) FDA has recognized a relevant consensus standard."
No 510(k)s were granted "expedited" status in 2009, according to the report.
The report indicates that the number of investigational device exemption applications last year rose, up 2.8 percent from 216 IDEs in 2008, compared with 222 during 2009.
Here’s how the data breaks down:
| TYPE OF SUBMISSION | 1999* | 2000* | 2001* | 2002* | 2003* | 2004 | 2005 | 2006 | 2007 | 2008 | 2009 |
| Original PMAs | 64 | 67 | 71 | 49 | 54 | 37 | 43 | 25 | 31 | 26 | 20 |
| PMA Supplements | 557 | 546 | 641 | 645 | 666 | 565 | 712 | 1,113 | 1,087 | 1,448 | 1,394 |
| Original IDEs | 304 | 311 | 283 | 312 | 242 | 222 | 226 | 251 | 211 | 216 | 222 |
| IDE Supplements | 4,127 | 4,388 | 4,810 | 4,722 | 4,415 | 4,297 | 4,264 | 4,485 | 4,345 | 4,409 | 4,281 |
| 510(k)s | 4,458 | 4,202 | 4,248 | 4,320 | 4,247 | 3,107 | 3,130 | 3,240 | 3,192 | 3,363 | 3,597 |
| Original HDE | 12 | 11 | 5 | 5 | 10 | 9 | 4 | 4 | 6 | 3 | 3 |
| HDE Supplements | 4 | 10 | 16 | 16 | 29 | 28 | 24 | 53 | 23 | 40 | 40 |
| 513(g)s | 43 | 59 | 82 | 104 | 156 | 239 | 287 | 244 | 381 | 96 | 98 |
| Total | 9,569 | 9,594 | 10,156 | 10,192 | 9,819 | 8,504 | 8,690 | 9,415 | 9,276 | 9,601 | 9,655 |
* Includes data from both the Office of Device Evaluation and the Office of In Vitro Diagnostic Device Evaluation and Safety
