Table 1

Number of devices with machine-readable summaries by FDA/CDRH Advisory Committee and year, share with software and share of software sample with cybersecurity content by Advisory Committee

YearFDA/CDRH Advisory Committee
Clinical chemistryCardiovascularDentalGastroenterology, urologyGeneral hospitalOrthopaedicRadiologyGeneral, plastic surgeryTotals
(CH)(CV)(DE)(GU)(HO)(OR)(RA)(SU)
20022164363182153284032903672573
20031924412952333293893293572565
20042043952841952704643453192476
20051553892451662624803103312338
20061974122931422444423383622430
20071533582831602574442713192245
20081493872791392074773253702333
20091304422681552544322903162287
20101213902451572804282353122168
20111634282581412415423472852405
20121554262401662825513443022466
20131854282351532025543463012404
20141304002251992455833853422509
20151083922441791745753403222334
2016953682301712044643753542261
Totals 2353609239422571377972284870495935 794
Share with software (‘software sample’)9.14%18.99%4.59%8.01%4.97%1.36%52.28%6.96%13.79%
Share of software sample with cybersecurity content7.91%2.51%1.66%0.00%2.13%0.00%2.04%0.00%2.13%
  • CDRH, Center for  Devices and Radiological Health; FDA, Food and Drug Administration.