Table 1.

Medical devices receiving marketing authorization fiscal year 2015 through fiscal year 2020 analyzed in this study, organized by CDRH OHT

Office of health technology	PMA	510 (k)	De Novo	HDE
OHT 1 (ophthalmic/anesthesia/respiratory/ear nose & throat/dental devices)	13%	23%	22%	8%
	n = 35	n = 47	n = 17	n = 1
OHT 2 (cardiovascular devices)	49%	21%	13%	25%
	n = 131	n = 42	n = 10	n = 3
OHT 3 (reproductive/gastro-renal/urological/general hospital devices and human factors)	7%	14%	23%	33%
	n = 18	n = 29	n = 18	n = 4
OHT 4 (neurological/psychiatric/physical medicine devices)	7%	20%	17%	0%
	n = 19	n = 40	n = 13	n = 0
OHT 5 (neurological/physical medicine devices)	7%	10%	18%	8%
	n = 20	n = 20	n = 14	n = 1
OHT 6 (orthopedic devices)	8%	5%	3%	25%
	n = 21	n = 11	n = 2	n = 3
OHT 7 (in vitro diagnostics*/radiological health)	9%	6%	5%	0%
	n = 24	n = 12	n = 4	n = 0
Total	n = 268	n = 201	n = 78	n = 12

Medical specialties within each OHT are listed in parentheses. Total number of marketing authorizations analyzed in this study, stratified by OHT and authorization type, are presented as “n” in each cell. *Only devices reviewed by the Clinical Chemistry advisory committee in OHT 7 were included in the study (numbers in table reflect this)