RAC-FINAL EXAM QUESTIONS WITH
ALL ACCURATE ANSWERS/LATEST
UPDATE.
Design Dossier - Answer - For Class III medical devices.
- This document provides a complete record of the design and development of the medical
device, including design inputs, design outputs, verification and validation activities, and design
changes.
Validation Master Plan (VMP) - Answer -outlines the principles involved in facility qualification,
defining the areas and systems to be validated
- should include process validation, facility and utility qualification and validation, equipment
qualification, cleaning, and computer validation
- provides a written program for achieving and maintaining a qualified facility with validated
processes
Validation info should include: - Answer method used, sterility assurance level attained,
standards applied, sterilization protocol, summary of results
Rule 9 - Answer Active devices intended to administer or exchange energy or emit ionizing
radiation.
IIa - III depending on if implant, monitoring performance of devices
Rule 14 - Answer Devices incorporating a medicinal product (with drug as ancillary action) -
Class III
Medical Device Listing (21 CFR 807) - Answer Most medical device establishments required to
register with FDA also must list their devices in commercial distribution (21 CFR 807), including
those produce exclusively for export. This medical device listing is a means of keeping FDA
advised of the device categories an establishment is manufacturing or marketing.
Initial importers would not list the device but point to the manufacturer instead. Devices only
intended for export outside of US also need to be registered and device listed
Reminder that diagnostic devices that are hooked up to someone ARE NOT IVDs. - Answer
Continuous blood glucose monitoring systems, pulse oximeter are regulated as medical devices
because they act in vivo.
,An enact law is know as _____ - Answer Statute
Private law affects what? - Answer An individual or small group
A public law affects society as whole, food and drugs, which fall under _____ - Answer FD&C
Act
What do regulations interpret? - Answer Laws and describe how they will be enforced
Rulemaking is governed by? - Answer Administrative Procedure Act of 1964 (APA)
Th process by which FDA proposes and establishes regulations is called - Answer Rulemaking
Administrative Procedure Act requires agencies to do what? - Answer Keep the public
informed and gives the public the right to participate in the Rulemaking process by commenting
on proposed regulations
Sunshine Act of 1976 - Answer Requires advance notice of Rulemaking meetings and that
those meetings be open to the public
New regulations or changes to existing regulations are announced in - Answer Federal Register
Pure Food and Drug Act of 1906 - Answer Prohibited misbranded and adulterated food, drinks,
and drugs from entering interstate commerce.
All products must have proper labeling and list all ingredients (products cannot be misbranded).
Sherley Amendment - Answer Prohibited labeling medicines with false therapeutic claims
intended to defraud the purchaser
FD&C Act - Answer Established criteria for food to be considered adulterated, mislabeled, or
harmful
Durham-Humphrey Amendment - Answer Clarified what constitutes a prescription versus an
over-the-counter drug
,Food Additives Amendment - Answer Enacted to delineate substances added to food products
generally recognized as safe and substances that may affect food characteristics that were not
GRAS and required marketing approval
Kefauver-Harris Amendment aka Drug Amendment - Answer Address standards for both safety
and efficacy that must be met before a drug maybe marketed in the US
Orphan Drug Act of 1983 - Answer Act guarantees an orphan product developer seven years
of market exclusivity following FDA's approval. Incentives also include tax credits for clinical
research undertaken by a sponsor to generate data required for marketing approval.
Safe Medical Device Act (SMDA) of 1990 - Answer Device user facilities must report device-
related deaths to FDA and the manufacturer if known.
Device user facilities must report device-related serious injuries to the manufacturer or FDA if
manufacturer is not known.
Defined substantial equivalence.
Required 510(k) submitters to 510(k) clearance prior to marketing a device.
Gave FDA authority to regulate combination devices.
Defined the humanitarian device exemption.
Medical Device Amendment of 1992 - Answer Clarify certain terms and establish a single
reporting standard for device user facilities, manufacturers, importers, and distributors
Drug Price Competition and Patent Term Restoration Act of 1984 - Answer Established a
process for approving drugs based on comparison to an already approved product and provided
exclusive status for a period based on the length of the new drug's approval process or the
branded drug patent status for generics
How is a bio similar product approved? - Answer Based on similarity to FDA-approved
biological product.
Prescription Drug User Fee (PDUFA) - Answer Authorized FDA to collect user fees from
companies submitting applications for certain human drug and biological products.
, Medical Device User Fee and Modernization Act - Answer Required medical device companies
to pay fees to FDA to support the process of reviewing medical device applications
Food And Drug Administration Safety and Innovation Act - Answer Extended FDA's authority to
collect user fees from the generic drug and biologics industries
User fees are subject to reauthorization by Congresss every fiver years under _____ Act -
Answer FDA Reauthorization Act
Food and Drug Administration Modernization Act of 1997 - Answer Provided additional
authority for drug and biologic post marketing studies' monitoring.
Required FDA to issue regulations allowing clinical study sponsors to modify any investigational
device or study protocol by submitting a "Notice of Change" five days after instituting such a
change, where the changes(s) did not affect study design or patient safety significantly.
FDA Food Safety Modernization Act - Answer Focus: preventing food-borne illness.
Passed in 2011 in response to the continued threat from our food supply.
FDA: inspection mandate and new legal powers.
Food and Drug Administration Safety and Innovation Act (FDASIA) - Answer Under this act,
existing user fees were reauthorized, and FDA was given authority to collect user feeds to funds
reviews of generics and biosimilar biologics
Generating Antibiotic Incentives Now (GAIN) - Answer Provides incentives, such as fast-track,
priority review, and a five-year exclusivity extension for certain applications for the development
of antibacterial and antifungal drugs that treat serious or life-threatening infections designated
as qualified infections disease product.
2013 Drug Quality and Security Act (DQSA) - Answer FDA tracking system for bulk
compounding supplies
Improving Regulatory Transparency for New Medical Therapies Act of 2015 - Answer Amended
the Controlled Substances Act to require DEA to schedule a drug by issuing an interim final rule
within 90 days of receiving a recommendation.
21st Century Cures Act (CCA) - Answer This Act was passed in large part to streamline and add
flexibility and innovation to the drug development and approval process, primarily by creating
ALL ACCURATE ANSWERS/LATEST
UPDATE.
Design Dossier - Answer - For Class III medical devices.
- This document provides a complete record of the design and development of the medical
device, including design inputs, design outputs, verification and validation activities, and design
changes.
Validation Master Plan (VMP) - Answer -outlines the principles involved in facility qualification,
defining the areas and systems to be validated
- should include process validation, facility and utility qualification and validation, equipment
qualification, cleaning, and computer validation
- provides a written program for achieving and maintaining a qualified facility with validated
processes
Validation info should include: - Answer method used, sterility assurance level attained,
standards applied, sterilization protocol, summary of results
Rule 9 - Answer Active devices intended to administer or exchange energy or emit ionizing
radiation.
IIa - III depending on if implant, monitoring performance of devices
Rule 14 - Answer Devices incorporating a medicinal product (with drug as ancillary action) -
Class III
Medical Device Listing (21 CFR 807) - Answer Most medical device establishments required to
register with FDA also must list their devices in commercial distribution (21 CFR 807), including
those produce exclusively for export. This medical device listing is a means of keeping FDA
advised of the device categories an establishment is manufacturing or marketing.
Initial importers would not list the device but point to the manufacturer instead. Devices only
intended for export outside of US also need to be registered and device listed
Reminder that diagnostic devices that are hooked up to someone ARE NOT IVDs. - Answer
Continuous blood glucose monitoring systems, pulse oximeter are regulated as medical devices
because they act in vivo.
,An enact law is know as _____ - Answer Statute
Private law affects what? - Answer An individual or small group
A public law affects society as whole, food and drugs, which fall under _____ - Answer FD&C
Act
What do regulations interpret? - Answer Laws and describe how they will be enforced
Rulemaking is governed by? - Answer Administrative Procedure Act of 1964 (APA)
Th process by which FDA proposes and establishes regulations is called - Answer Rulemaking
Administrative Procedure Act requires agencies to do what? - Answer Keep the public
informed and gives the public the right to participate in the Rulemaking process by commenting
on proposed regulations
Sunshine Act of 1976 - Answer Requires advance notice of Rulemaking meetings and that
those meetings be open to the public
New regulations or changes to existing regulations are announced in - Answer Federal Register
Pure Food and Drug Act of 1906 - Answer Prohibited misbranded and adulterated food, drinks,
and drugs from entering interstate commerce.
All products must have proper labeling and list all ingredients (products cannot be misbranded).
Sherley Amendment - Answer Prohibited labeling medicines with false therapeutic claims
intended to defraud the purchaser
FD&C Act - Answer Established criteria for food to be considered adulterated, mislabeled, or
harmful
Durham-Humphrey Amendment - Answer Clarified what constitutes a prescription versus an
over-the-counter drug
,Food Additives Amendment - Answer Enacted to delineate substances added to food products
generally recognized as safe and substances that may affect food characteristics that were not
GRAS and required marketing approval
Kefauver-Harris Amendment aka Drug Amendment - Answer Address standards for both safety
and efficacy that must be met before a drug maybe marketed in the US
Orphan Drug Act of 1983 - Answer Act guarantees an orphan product developer seven years
of market exclusivity following FDA's approval. Incentives also include tax credits for clinical
research undertaken by a sponsor to generate data required for marketing approval.
Safe Medical Device Act (SMDA) of 1990 - Answer Device user facilities must report device-
related deaths to FDA and the manufacturer if known.
Device user facilities must report device-related serious injuries to the manufacturer or FDA if
manufacturer is not known.
Defined substantial equivalence.
Required 510(k) submitters to 510(k) clearance prior to marketing a device.
Gave FDA authority to regulate combination devices.
Defined the humanitarian device exemption.
Medical Device Amendment of 1992 - Answer Clarify certain terms and establish a single
reporting standard for device user facilities, manufacturers, importers, and distributors
Drug Price Competition and Patent Term Restoration Act of 1984 - Answer Established a
process for approving drugs based on comparison to an already approved product and provided
exclusive status for a period based on the length of the new drug's approval process or the
branded drug patent status for generics
How is a bio similar product approved? - Answer Based on similarity to FDA-approved
biological product.
Prescription Drug User Fee (PDUFA) - Answer Authorized FDA to collect user fees from
companies submitting applications for certain human drug and biological products.
, Medical Device User Fee and Modernization Act - Answer Required medical device companies
to pay fees to FDA to support the process of reviewing medical device applications
Food And Drug Administration Safety and Innovation Act - Answer Extended FDA's authority to
collect user fees from the generic drug and biologics industries
User fees are subject to reauthorization by Congresss every fiver years under _____ Act -
Answer FDA Reauthorization Act
Food and Drug Administration Modernization Act of 1997 - Answer Provided additional
authority for drug and biologic post marketing studies' monitoring.
Required FDA to issue regulations allowing clinical study sponsors to modify any investigational
device or study protocol by submitting a "Notice of Change" five days after instituting such a
change, where the changes(s) did not affect study design or patient safety significantly.
FDA Food Safety Modernization Act - Answer Focus: preventing food-borne illness.
Passed in 2011 in response to the continued threat from our food supply.
FDA: inspection mandate and new legal powers.
Food and Drug Administration Safety and Innovation Act (FDASIA) - Answer Under this act,
existing user fees were reauthorized, and FDA was given authority to collect user feeds to funds
reviews of generics and biosimilar biologics
Generating Antibiotic Incentives Now (GAIN) - Answer Provides incentives, such as fast-track,
priority review, and a five-year exclusivity extension for certain applications for the development
of antibacterial and antifungal drugs that treat serious or life-threatening infections designated
as qualified infections disease product.
2013 Drug Quality and Security Act (DQSA) - Answer FDA tracking system for bulk
compounding supplies
Improving Regulatory Transparency for New Medical Therapies Act of 2015 - Answer Amended
the Controlled Substances Act to require DEA to schedule a drug by issuing an interim final rule
within 90 days of receiving a recommendation.
21st Century Cures Act (CCA) - Answer This Act was passed in large part to streamline and add
flexibility and innovation to the drug development and approval process, primarily by creating
