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U.S. Department of Health and Human Services

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.

Accomplishment: ODE successfully completed all actions under its “Improve 510(k) Submission Quality” project. Significant accomplishments include: a Corrective and Preventive Action (CAPA) system; the Refuse to Accept (RTA) policy; a document management (DocMan) system; and the 5MART template. The template, completed in FY 13, was created to help and guide premarket notification reviewers through their reviews. It takes advantage of automation by reading ("pulling") meta-data pertaining to a specific application (e.g., device name, submitting company name, company information, product codes, etc.) from CDRH databases, thereby increasing accuracy and speed or reviews. In addition, it uses software (Visual Basic for Applications; VBA) embedded in a Microsoft Word document to guide reviewers through review and documentation of the various sections of a 510(k) (e.g. sterility, software, biocompatibility, battery, EMC).

Briefing Status: Completed

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone 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

Completed 4/30/2013

R. Complete SMART Template User Acceptance Testing

6/30/2013

Completed 6/30/2012

S. Complete SMART Template Pilot (1-2 Divisions)

8/30/2013

Completed 7/31/2013

T. Roll-out SMART Template to ODE

10/31/2013

Completed 7/30/2013

Footnotes

  • Revised milestones are indicated in italics and parentheses beneath the original milestone date.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - 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.