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DEVICE REGULATORY AFFAIRS CERTIFICATION (RAC)
(ACTUAL 2025/2026) EXAM QUESTIONS AND
VERIFIED ANSWERS
Pure Food and Drug Act of 1906 - (answers)the first of a series of significant
consumer protection laws which was enacted by Congress in the 20th century and
led to the creation of the Food and Drug Administration
Slip Law - (answers)First official publication of a statute is in the form of a slip law
Sherley Amendment - (answers)prohibited labeling medicines with false
therapeutic claims. The burden to prove intent rests with the government.
FD&C Act - (answers)Roosevelt signed after sulfanilamide tragedies. 1938.
Required manufacturers to provide scientific proof that new drugs were safe,
cosmetics and medical devices added, adding poisonous substances was
prohibited unless absolutely necessary. Repealed Pure Food and Drug Act of 1906.
Public Health Service Act of 1944 - (answers)gave FDA authority over vaccines and
serums, aka Biologics
Durham-Humphrey Amendment - (answers)1951. Clarified the difference
between prescription drugs and OTC
Food Additives Amendment - (answers)1958. Was added to delineate substances
added to food products generally recognized as safe
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Kefauver-Harris Amendment aka Drug Amendments of 1962 -
(answers)Thalidomide. Addressed standards for both safety and efficacy that
must be met
Medical Device Amendments of 1976 - (answers)· Refined MDs to distinguish
from drugs and included diagnostics for conditions other than disease
· Established device safety and performance effectiveness requirements
· Established FDA premarket review
· Established the MD classification system
· Created two routes to market (premarket notification and premarket approval)
and established the IDE (Investigational Device Exemption)
Medical Device Amendments - (answers)1979. Result of the Cooper Report
stating many injuries and death were a result of medical devices. Established 3
medical device classes. Provided provisions for Device Listing, establishment
registration, and following of GMPs
Orphan Drug Act of 1983 - (answers)for rare diseases (less than 200,000 persons
in US). Gives manufacturers 7 years of market exclusivity following approval
Safe Medical Devices Act of 1990 - (answers)Device user facilities must report
deaths to the FDA. Incorporated QSR. Instituted device tracking and post market
surveillance. Created orphan or humanitarian use device (less than 4,000
cases/year)
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· Required high-risk device tracking
· Defined SE
· Required 510(k) submitters to receive FDA clearance before market
· FDA has power to regulate combo products
o Agency must designate a center to head the review (CBER, CDER, CDRH)
· Defined the HDE (Humanitarian Device Exemption)
· Gave FDA recall authority
Medical Device Amendments of 1992 - (answers)clarified terms and established a
single reporting standard
Hatch-Waxman Act aka Drug Price Competition and Patent Term Restoration Act -
(answers)established a process for approving drugs based on comparison to an
already approved drug. Created ANDA process
Biologics Price Competition and Innovation Act - (answers)similar to Drug Price
Competition and Patent Term Restoration Act for approval for biosimilar.
PDUFA - (answers)Prescription Drug User Fee Act - First enacted in 1992.
Authorized FDA to collect fees for certain drug applications
MDUFMA - (answers)Medical Device User Fee and Modernization Act - Allowed
FDA to collect user fees for medical device applications (PMAs and 510Ks)
DEVICE REGULATORY AFFAIRS CERTIFICATION (RAC)
(ACTUAL 2025/2026) EXAM QUESTIONS AND
VERIFIED ANSWERS
Pure Food and Drug Act of 1906 - (answers)the first of a series of significant
consumer protection laws which was enacted by Congress in the 20th century and
led to the creation of the Food and Drug Administration
Slip Law - (answers)First official publication of a statute is in the form of a slip law
Sherley Amendment - (answers)prohibited labeling medicines with false
therapeutic claims. The burden to prove intent rests with the government.
FD&C Act - (answers)Roosevelt signed after sulfanilamide tragedies. 1938.
Required manufacturers to provide scientific proof that new drugs were safe,
cosmetics and medical devices added, adding poisonous substances was
prohibited unless absolutely necessary. Repealed Pure Food and Drug Act of 1906.
Public Health Service Act of 1944 - (answers)gave FDA authority over vaccines and
serums, aka Biologics
Durham-Humphrey Amendment - (answers)1951. Clarified the difference
between prescription drugs and OTC
Food Additives Amendment - (answers)1958. Was added to delineate substances
added to food products generally recognized as safe
,2|Page
Kefauver-Harris Amendment aka Drug Amendments of 1962 -
(answers)Thalidomide. Addressed standards for both safety and efficacy that
must be met
Medical Device Amendments of 1976 - (answers)· Refined MDs to distinguish
from drugs and included diagnostics for conditions other than disease
· Established device safety and performance effectiveness requirements
· Established FDA premarket review
· Established the MD classification system
· Created two routes to market (premarket notification and premarket approval)
and established the IDE (Investigational Device Exemption)
Medical Device Amendments - (answers)1979. Result of the Cooper Report
stating many injuries and death were a result of medical devices. Established 3
medical device classes. Provided provisions for Device Listing, establishment
registration, and following of GMPs
Orphan Drug Act of 1983 - (answers)for rare diseases (less than 200,000 persons
in US). Gives manufacturers 7 years of market exclusivity following approval
Safe Medical Devices Act of 1990 - (answers)Device user facilities must report
deaths to the FDA. Incorporated QSR. Instituted device tracking and post market
surveillance. Created orphan or humanitarian use device (less than 4,000
cases/year)
, 3|Page
· Required high-risk device tracking
· Defined SE
· Required 510(k) submitters to receive FDA clearance before market
· FDA has power to regulate combo products
o Agency must designate a center to head the review (CBER, CDER, CDRH)
· Defined the HDE (Humanitarian Device Exemption)
· Gave FDA recall authority
Medical Device Amendments of 1992 - (answers)clarified terms and established a
single reporting standard
Hatch-Waxman Act aka Drug Price Competition and Patent Term Restoration Act -
(answers)established a process for approving drugs based on comparison to an
already approved drug. Created ANDA process
Biologics Price Competition and Innovation Act - (answers)similar to Drug Price
Competition and Patent Term Restoration Act for approval for biosimilar.
PDUFA - (answers)Prescription Drug User Fee Act - First enacted in 1992.
Authorized FDA to collect fees for certain drug applications
MDUFMA - (answers)Medical Device User Fee and Modernization Act - Allowed
FDA to collect user fees for medical device applications (PMAs and 510Ks)
