Table 2.

Current Postmarketing Activity Regulations for Drugs and Medical Devices and Putative Requirements for Tobacco Products Under the FDA

	Drugs/biologics	Medical devices	Tobacco products
Applicable products	Prescription drugs and biological agents	Class II and III devices	Products with a “modified-risk” or “reduced-exposure” claim
FDA can require postmarket study as condition of approval	Yes, via PMRs, including laboratory and epidemiological studies or clinical trials with safety endpoint	Yes, for products subject to PMA	Yes
FDA can require new postmarket study for already approved product	Yes, if signal identified and existing reporting and surveillance systems are insufficient	Yes, if signal identified or product was recalled or subject to corrective action	Yes, on renewal of MRTP approval
Mandated reporting	AERS	AERS
		MAUDE
Spontaneous reporting	MedWatch	MedWatch
Surveillance structures	NEISS	NEISS	NSDUH
	DAWN	MedSUN	NHIS
	NSDUH		NHANES
			CPS-TUS
			BRFSS
Risk evaluation and mitigation strategy	Yes, for selected products	No

Note. AERS = adverse event reporting system; BRFSS = Behavioral Risk Factor Surveillance System; CPS-TUS = Current Population Survey Tobacco Use Supplement; DAWN = Drug Abuse Warning Network; NEISS = National Electronic Injury Surveillance System; NHANES = National Health and Nutrition Examination Survey; NHIS = National Health Interview Survey; NSDUH = National Survey on Drug Use and Health; MedSUN = Medical Product Safety Network; MRTP = modified-risk tobacco product; PMA = premarket approval; PMR = postmarketing requirement.