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RAC EXAM Questions and Answers
Latest 2026
Design Dossier Ans: - 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) Ans: -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: Ans: method used,
sterility assurance level attained, standards applied,
sterilization protocol, summary of results
Rule 9 Ans: Active devices intended to administer or
exchange energy or emit ionizing radiation.
© 2025 All rights reserved
, 2 | Page
IIa - III depending on if implant, monitoring performance
of devices
Rule 14 Ans: Devices incorporating a medicinal product
(with drug as ancillary action) - Class III
Medical Device Listing (21 CFR 807) Ans: 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. Ans: Continuous blood glucose
monitoring systems, pulse oximeter are regulated as
medical devices because they act in vivo.
An enact law is know as _____ Ans: Statute
Private law affects what? Ans: An individual or small
group
A public law affects society as whole, food and drugs,
which fall under _____ Ans: FD&C Act
What do regulations interpret? Ans: Laws and describe
how they will be enforced
© 2025 All rights reserved
, 3 | Page
Rulemaking is governed by? Ans: Administrative
Procedure Act of 1964 (APA)
Th process by which FDA proposes and establishes
regulations is called Ans: Rulemaking
Administrative Procedure Act requires agencies to do
what? Ans: 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 Ans: 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 Ans: Federal Register
Pure Food and Drug Act of 1906 Ans: 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 Ans: Prohibited labeling medicines
with false therapeutic claims intended to defraud the
purchaser
FD&C Act Ans: Established criteria for food to be
considered adulterated, mislabeled, or harmful
© 2025 All rights reserved
, 4 | Page
Durham-Humphrey Amendment Ans: Clarified what
constitutes a prescription versus an over-the-counter
drug
Food Additives Amendment Ans: 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 Ans:
Address standards for both safety and efficacy that must
be met before a drug maybe marketed in the US
Orphan Drug Act of 1983 Ans: 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 Ans: 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.
© 2025 All rights reserved
RAC EXAM Questions and Answers
Latest 2026
Design Dossier Ans: - 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) Ans: -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: Ans: method used,
sterility assurance level attained, standards applied,
sterilization protocol, summary of results
Rule 9 Ans: Active devices intended to administer or
exchange energy or emit ionizing radiation.
© 2025 All rights reserved
, 2 | Page
IIa - III depending on if implant, monitoring performance
of devices
Rule 14 Ans: Devices incorporating a medicinal product
(with drug as ancillary action) - Class III
Medical Device Listing (21 CFR 807) Ans: 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. Ans: Continuous blood glucose
monitoring systems, pulse oximeter are regulated as
medical devices because they act in vivo.
An enact law is know as _____ Ans: Statute
Private law affects what? Ans: An individual or small
group
A public law affects society as whole, food and drugs,
which fall under _____ Ans: FD&C Act
What do regulations interpret? Ans: Laws and describe
how they will be enforced
© 2025 All rights reserved
, 3 | Page
Rulemaking is governed by? Ans: Administrative
Procedure Act of 1964 (APA)
Th process by which FDA proposes and establishes
regulations is called Ans: Rulemaking
Administrative Procedure Act requires agencies to do
what? Ans: 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 Ans: 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 Ans: Federal Register
Pure Food and Drug Act of 1906 Ans: 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 Ans: Prohibited labeling medicines
with false therapeutic claims intended to defraud the
purchaser
FD&C Act Ans: Established criteria for food to be
considered adulterated, mislabeled, or harmful
© 2025 All rights reserved
, 4 | Page
Durham-Humphrey Amendment Ans: Clarified what
constitutes a prescription versus an over-the-counter
drug
Food Additives Amendment Ans: 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 Ans:
Address standards for both safety and efficacy that must
be met before a drug maybe marketed in the US
Orphan Drug Act of 1983 Ans: 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 Ans: 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.
© 2025 All rights reserved
