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