RAC EXAM QUESTIONS WITH
100% CORRECT ANSWERS
A deficiency letter may be issued to a company during a Biologics License Application
(BLA) review for which of the following? - Answer- Clinical testing did not include
enough subjects
Company X is developing marketing materials for a Class II medical device known as
"Y." In one marketing piece, the company talks about the clinical data supporting the
device's marketing. Which of the following statements is illegal and should NOT be
included in the marketing materials? - Answer- Class II devices are cleared for
marketing in the US by FDA, not approved.
A manufacturer changes the size and shape of a container for a nonsterile solid dosage
form drug already approved by FDA. What would be the most
appropriate postapproval vehicle for this potential action? - Answer- Annual Report.
What is Form 2253 - Answer- Transmittal of Advertisements and Promotional Labeling
for Drugs
What is the exception for the use of form FDA 2253 - Answer- products approved under
accelerated
approval, which must be submitted for advisory
opinion 30 days prior to initial dissemination.
Form 1571 - Answer- Cover sheet for an IND application, contract between FDA and
Sponsor
Form 3674 - Answer- ClinicalTrials.gov Data Bank
CERTIFICATION OF COMPLIANCE
Form 3674 must accompany an application/submission, including certain amendments,
supplements, and
resubmissions, submitted under §§ 505, 515, 520(m), or 510(k) of the Federal Food,
Drug, and Cosmetic Act
or § 351 of the Public Health Service Act.
21 CFR 601 Subpart H - Answer- animal rule
, A company begins to market its new device, a pacemaker (Class III) the same day its
regulatory professional submits the Premarket Approval Application (PMA) to FDA. The
pacemaker is considered: - Answer- Adulterated
A company manufactures a combination internal analgesic product, regulated under a
tentative final monograph. An Advisory Committee meeting is being planned to discuss
potentially lowering either the maximum daily dose of one of the internal analgesic
active ingredients, or limiting the single dosage unit. This will impact your product, and
you plan to provide safety and efficacy data to FDA to support the currently existing
dosing regimen for your product. How, as the regulatory professional, do you
communicate with FDA regarding this topic? - Answer- Citizen's Petition
A company is planning to implement a few minor manufacturing changes for its FDA-
approved device. The company currently is conducting a clinical study for a
new indication for the device. The correct submission type is: - Answer- IDE 5-day
Notice
An investigator wishing to begin a clinical investigation using xenotransplantation must
submit the following: - Answer- IND
An applicant wants to manufacture an approved tablet at a site that currently produces
capsules and has a satisfactory GMP inspection for capsule production.
What type of submission would be required for this change? - Answer- Prior Approval
Supplement is required because the manufacturing process is different.
How should an NDA holder report a change to aseptic processing filtration parameters
(including flow rate, pressure, time or volume, but not filter material or
pore size rating). - Answer- Changes Being Effected in 30-Days
Meetings Created by FDAMA 1997 - Answer- Agreement Meetings and Determination
Meetings
How long after proprietary name submission does FDA provided a tentative acceptance
or non acceptance letter? - Answer- 90 days
How long does FDA have to review an RFD - Answer- 60 days (combination product)
FDA Form 3356 - Answer- Establishment Registration and Listing for HCT/Ps (still
allowed)
Device History Record (DHR) - Answer- Record of every device built.
Device Master Record (DMR) - Answer- Everything you need to know to build and test
the device is contained here. The DMR is focused on the device and ensuring you have
all of the necessary items to build, test, package, and service it.
100% CORRECT ANSWERS
A deficiency letter may be issued to a company during a Biologics License Application
(BLA) review for which of the following? - Answer- Clinical testing did not include
enough subjects
Company X is developing marketing materials for a Class II medical device known as
"Y." In one marketing piece, the company talks about the clinical data supporting the
device's marketing. Which of the following statements is illegal and should NOT be
included in the marketing materials? - Answer- Class II devices are cleared for
marketing in the US by FDA, not approved.
A manufacturer changes the size and shape of a container for a nonsterile solid dosage
form drug already approved by FDA. What would be the most
appropriate postapproval vehicle for this potential action? - Answer- Annual Report.
What is Form 2253 - Answer- Transmittal of Advertisements and Promotional Labeling
for Drugs
What is the exception for the use of form FDA 2253 - Answer- products approved under
accelerated
approval, which must be submitted for advisory
opinion 30 days prior to initial dissemination.
Form 1571 - Answer- Cover sheet for an IND application, contract between FDA and
Sponsor
Form 3674 - Answer- ClinicalTrials.gov Data Bank
CERTIFICATION OF COMPLIANCE
Form 3674 must accompany an application/submission, including certain amendments,
supplements, and
resubmissions, submitted under §§ 505, 515, 520(m), or 510(k) of the Federal Food,
Drug, and Cosmetic Act
or § 351 of the Public Health Service Act.
21 CFR 601 Subpart H - Answer- animal rule
, A company begins to market its new device, a pacemaker (Class III) the same day its
regulatory professional submits the Premarket Approval Application (PMA) to FDA. The
pacemaker is considered: - Answer- Adulterated
A company manufactures a combination internal analgesic product, regulated under a
tentative final monograph. An Advisory Committee meeting is being planned to discuss
potentially lowering either the maximum daily dose of one of the internal analgesic
active ingredients, or limiting the single dosage unit. This will impact your product, and
you plan to provide safety and efficacy data to FDA to support the currently existing
dosing regimen for your product. How, as the regulatory professional, do you
communicate with FDA regarding this topic? - Answer- Citizen's Petition
A company is planning to implement a few minor manufacturing changes for its FDA-
approved device. The company currently is conducting a clinical study for a
new indication for the device. The correct submission type is: - Answer- IDE 5-day
Notice
An investigator wishing to begin a clinical investigation using xenotransplantation must
submit the following: - Answer- IND
An applicant wants to manufacture an approved tablet at a site that currently produces
capsules and has a satisfactory GMP inspection for capsule production.
What type of submission would be required for this change? - Answer- Prior Approval
Supplement is required because the manufacturing process is different.
How should an NDA holder report a change to aseptic processing filtration parameters
(including flow rate, pressure, time or volume, but not filter material or
pore size rating). - Answer- Changes Being Effected in 30-Days
Meetings Created by FDAMA 1997 - Answer- Agreement Meetings and Determination
Meetings
How long after proprietary name submission does FDA provided a tentative acceptance
or non acceptance letter? - Answer- 90 days
How long does FDA have to review an RFD - Answer- 60 days (combination product)
FDA Form 3356 - Answer- Establishment Registration and Listing for HCT/Ps (still
allowed)
Device History Record (DHR) - Answer- Record of every device built.
Device Master Record (DMR) - Answer- Everything you need to know to build and test
the device is contained here. The DMR is focused on the device and ensuring you have
all of the necessary items to build, test, package, and service it.
