About FDA
Improve 510(k) Submission Quality
Description: CDRH receives approximately 4,000 510(k) applications per year. The review of a 510(k) is directly affected by the quality of the application. Poor submission quality requires additional FDA resources and leads to longer times before a 510(k) device gets to market. 510(k) submission quality of paper only copies is difficult to measure directly. This project uses a multi-pronged approach to evaluate various surrogates of submission quality, including analysis of additional information letters, a reviewer survey, and evaluation of the e-Copy initiative.
Briefing Status: ON TRACK
Prior Briefing Status: ON TRACK
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
A. Collect input from Office of Device Evaluation (ODE), OIVD (Office of In Vitro Diagnostics Evaluation and Safety (OIVD), and Center for Biologics Evaluation and Research (CBER) review staff to assess premarket submission quality using a web-based survey tool |
12/31/2010 |
Completed | 12/1/2010 |
|
B. Complete analysis of survey results |
1/31/2011 |
Completed | 2/10/2011 |
|
C. Complete analysis of a representative sample of 510(k) first action requests from Additional Information (AI) Letters & emails to determine the type & rate of deficiencies identified during the first review cycle |
1/31/2011 |
Completed | 2/28/2011 |
|
D. Develop a study plan to determine the usage of the e-Copy initiative for 510(k) applications |
3/11/2011 |
Completed | 3/11/2011 |
|
E. Begin sending usable CDs to the Reviewers/Math Statisticians to expedite data analysis of clinical data |
3/14/2011 |
Completed | 3/14/2011 |
|
F. Begin tracking incoming e-Copies of 510(k)s over a three month period by the Document Control Center (DCC). DCC will record successes and problems of e-Copy 510(k)s. |
6/30/2011 |
Completed | 6/30/2011 |
|
G. Prepare recommendation report based on findings of A through F |
7/31/2011 (9/30/2011) |
Completed | 10/3/2011 |
|
H. Corrective and Preventive Action (CAPA) system will go "live" |
10/1/2011 |
Completed | 10/1/2011 |
|
I. Begin the 510(k) Refuse to Accept (RTA) pilot study |
11/14/2011 |
Completed | 11/14/2011 |
|
J. Complete pilot and receive feedback from reviewers |
12/31/2011 |
Completed | 12/23/2011 |
|
K. Complete pilot analysis |
2/29/2012 |
Completed | 1/31/2012 |
|
L. Complete draft checklist and policy |
6/30/2012 |
Completed | 6/30/2012 |
|
M. Complete final RTA policy |
10/1/2012 |
Completed | 12/31/2012 |
|
N. Implement the 510(k) Refuse to Accept policy |
10/1/2012 |
Completed | 1/1/2013 |
|
O. Develop DocMan and complete initial testing |
12/31/2012 |
Completed | 12/31/2012 |
|
P. Complete DocMan User Acceptance Testing |
1/31/2013 |
Completed | 1/31/2013 |
|
Q. Develop SMART Template and complete initial testing |
4/30/2013 |
On Track | |
|
R. Complete SMART Template User Acceptance Testing |
6/30/2013 |
Not Yet Started | |
|
S. Complete SMART Template Pilot (1-2 Divisions) |
8/30/2013 |
Not Yet Started | |
|
T. Roll-out SMART Template to ODE |
10/31/2013 |
Not Yet Started |
Footnotes
- Revised milestones are indicated in italics and parentheses beneath the original milestone date.
Key Projects Legend
| Milestone Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |
Glossary
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.
