Summary of FDA's Inspectional Observation Data Sets
(based on data provided by FDA at http://www.fda.gov/ICECI/Inspections/ucm250720.htm)
Based on the most recently available data from FDA. Years are FDA fiscal years.
Table 1. Summary of FDA 483 Citations (2006-2014) |
Year |
Number of 483's Issued for all Medical Devices |
Software-related Citations |
2006 |
887 |
95 |
2007 |
831 |
99 |
2008 |
776 |
71 |
2009 |
778 |
71 |
2010 |
976 |
51 |
2011 |
1035 |
59 |
2012 |
1090 |
58 |
2013 |
1099 |
56 |
2014 |
972 |
45 |
Note: warning letters are the next step after a 483; they are issued when FDA feels that a company has not responded adequately to observations noted on a form 483, or the 483 is considered a serious violation. On this web page, the terms "483," and "inspectional observation" are used interchangeably. A single 483 may consist of more than one "citation."
We searched the complete set of 2006-2014 FDA Inspectional Observations for software-related key words; the only search term that turned anything up was "software." 605 of the citations were for software.
Table 2. Software-related citations by Search Term |
Search Term |
Number of Inspectional Observations (see details in table 3) |
Software |
605 |
Firmware |
0 |
62304 |
0 |
Table 3. Detailed Summary of the 605 Software-related Inspectional Observations (2006-2014) |
Topic Area |
Description |
Number of Citations |
Software validation for automated processes |
Software used as part of [production] [the quality system] has not been [adequately] validated for its intended use according to an established protocol. |
187 |
DMR device specifications |
The device master record does not include or refer to the location of device software specifications. |
185 |
Design validation - software validation not performed |
Validation of device software [was not performed] [is inadequate] [is incomplete]. |
102 |
Documentation of software validation |
Software validation activities and results for computers or automated data processing systems used as part of [production] [the quality system] have not been [adequately] documented. |
95 |
Design validation - software validation documentation |
Results of the validation of the device software were not [adequately] documented. |
25 |
Validation of changes to automated process software |
Changes to software used as part of [production] [the quality system] were not [adequately] validated before approval and issuance. |
11 |
Total: |
|
605 |