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Regulatory Affairs Certification - Medical Devices – Q&A
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Regulatory Affairs Certification - Medical Devices – Q&A
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Regulatory Affairs Certification - Medical Devices – Q&APure Food and Drug Act of 1906 ✔ Ans - 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 ✔ Ans - First official publication of a statute is in the form of a slip law
Sherley Amendment ✔ Ans - prohibited labeling medicines with false therapeutic claims. The burden to prove intent rests with the government.
FD&C Act ✔ Ans - 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 Repealed Pure Food and Drug Act of 1906.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 ✔ Ans - gave FDA authority over vaccines
and serums, aka Biologics
Durham-Humphrey Amendment ✔ Ans - 1951. Clarified the difference between prescription drugs and OTC
Food Additives Amendment ✔ Ans - 1958. Was added to delineate substances added to food products generally recognized as safe
Kefauver-Harris Amendment aka Drug Amendments of 1962 ✔ Ans - Thalidomide. Addressed standards for both safety and efficacy that must be met
Medical Device Amendments of 1976 ✔ Ans - · 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 ✔ Ans - 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 ✔ Ans - 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 ✔ Ans - 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)
· 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 ✔ Ans - clarified terms and established a single reporting standard
Hatch-Waxman Act aka Drug Price Competition and Patent Term Restoration Act ✔ Ans - established a process for approving drugs based on comparison to an already approved drug. Created ANDA process
Biologics Price Competition and Innovation Act ✔ Ans - similar to Drug Price Competition and Patent Term Restoration Act for approval for biosimilar.
PDUFA ✔ Ans - Prescription Drug User Fee Act - First enacted in 1992. Authorized FDA to collect fees for certain drug applications
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