2026 RAC (Regulatory Affairs
Certification) Practice Exam Update.
RAC Practice Exam Update Questions With
Complete Solutions
Question: A Special 510(k) must contain all of the following components EXCEPT:
• A. Proposed Labeling
• B. Design Controls Activity Summary
• C. 510(k) Summary or 510(k) Statement
• D. Summary of Safety and Effectiveness Data
• [Ans: - D. Summary of Safety and Effectiveness Data]
Explanation: Summary of Safety and Effectiveness Data is not a requirement of a
Special 510(k).
Legal Reference Fragment: Sec. 807.87 Information required in a premarket
notification submission. [...] (j) For submissions claiming substantial equivalence to a
device which ha[s been classified] under section 513(b) of the act: (1) Which was
introduced or delivered for introduction into interstate co[mmerce] for co[mmercial]
distribution before December 1, 1990; and (2) For which no final regulation requiring
premarket approval has been i[ssued...] of the act, a summary of the types of safety and
effectiveness problems a[nd] devices being compared and a citation to the information
upon which th[e summary is based (class III] summary). The 510(k) submitter shall also
,certify that a reasonable searc[h of all information known] or otherwise available about
the class III device and other similar legally [marketed devices has been] conducted
(class III certification), as described in 807.94. This informatio[n shall include any
adverse safety and effectiveness] information that already has been submitted to the
Food and Drug Admi[nistration under] section 519 of the act. FDA may require the
submission of the adverse sa[fety and effectiveness data] described in the class III
summary or citation.
Context Text: Demineralized bone matrix alone (i.e., not combined with another
comp[onent]) meets the four criteria to be regulated solely under Section 361 of the
P[HS Act]. FDA, however, has determined the addition of certain components to DB[M],
[like] calcium phosphates, meets the definition of a device as they are intend[ed to
provide] function of the body by assisting in the filling of bone voids. These DBM
p[roducts are] regulated as devices by CDRH (510(k) clearance required) and as such
mu[st follow the] Quality System Regulation. In addition, the product also needs to
comply [with] 21 CFR 1271 Human Cells, Tissues and Cellular and Tissue-Based
Product[s for the HCT/P] component.
Question: You work for a company that is developing an autologous cellular therap[y.
You tell] your company that its product will be regulated as an HCT/P (Human Cel[ls,
Tissues, and] Tissue-Based Product). Based on this information, with which of the
follo[wing regulatory] requirements will your company need to be compliant when
manufactur[ing it?]
• A. 21 CFR (CGMP requirements for pharmaceuticals)
• B. 21 CFR 1271 and 21 CFR 820
• C. All Subparts of 21 CFR 1271 except Subpart C (Donor Eligibility)
• D. All Subparts of 21 CFR 1271
• [Ans: - C. All Subparts of 21 CFR 1271 exce[pt Subpart C (Donor]
Eligibility)]
Explanation: As the product is regulated under section 361 of the PHS Act, it is only
su[bject to] 21 CFR 1271, with the exception of Subpart C, as autologous products ar[e
exempt from donor] eligibility requirements.
,Clinical Trial Context:
• —Trials of drugs and biologics: controlled clinical investigations, other th[an
those for] a product subject to FDA regulation
• —Trials of devices: (a) a prospective clinical study of health outcomes
co[mpared] with a device, subject to FDA regulation, against a control in human
subj[ects (including] feasibility studies), and (b) pediatric postmarket surveillance
Question: The two mechanisms to amend an OTC Monograph are:
• A. Time & Extent Application (TEA) or Annual Report
• B. Time & Extent Application (TEA) or Citizen Petition
• C. Annual Report or Preapproval Supplement
• D. Citizen Petition or Preapproval Supplement
• [Ans: - B. Time & Extent A[pplication (TEA) or Citizen] Petition]
Question: Which of the following is NOT required in a Biologics License Application
[BLA as compared to a] New Drug Application (NDA)?
• A. FDA form 3397 (user fee cover sheet)
• B. Field copy certification
• C. Chemistry section
• D. Debarment certification
• [Ans: - B. Field copy certification]
Explanation: Field copy certification only applies to NDA products, whereas all of the
o[ther choices are] requirements for both BLAs and NDAs.
Context Text: A treatment IND would be most suitable for this application (answer 1).
T[reatment INDs are intended] as a means of providing eligible subjects with
investigational drugs or bio[logics to treat] serious and life-threatening illnesses for
which there are no suitable alte[rnatives].
Question: You are assigned the task of obtaining an Orphan Drug Designation (ODD[)
for a] drug for new onset Type I diabetes mellitus. Which of the following is NO[T a]
consideration for this ODD application?
• A. The ODD application must be submitted for review to FDA Office of Or[phan
Products] Development (OOPD)
• B. This investigational drug may qualify for ODD as new onset Type I diab[etes is
a] medically plausible disease subset under the Orphan Drug Act
, • C. The ODD application must be submitted electronically to the OOPD t[hrough
the FDA] Submission Gateway (ESG)
• D. The scientific rationale and population prevalence are two areas of the
[application] most critically reviewed by FDA
• [Ans: - C. The ODD application must be su[bmitted to] the OOPD through
the FDA Electronic Submission Gateway (ESG)]
Explanation: Sponsors may send the submission directly to OOPD on physical media
with a sign[ed cover] letter.
Question: How many days does FDA have to review an Abbreviated 510(k)?
• A. 30 days
• B. 60 days
• C. 90 days
1. Which of the following must be submitted to FDA before
conducting a clinical investigation of a significant risk medical
device in the United States?
A. PMA
B. IDE
C. 510(k)
D. De Novo request
[Correct Ans - B. IDE]
Explanation:
An Investigational Device Exemption (IDE) is required to conduct a clinical study of a
significant risk device in order to collect safety and effectiveness data.
2. A 510(k) submission is based on a claim that a new device is:
A. Safe and effective
B. Identical to all marketed devices
C. Substantially equivalent to a legally marketed predicate device
Certification) Practice Exam Update.
RAC Practice Exam Update Questions With
Complete Solutions
Question: A Special 510(k) must contain all of the following components EXCEPT:
• A. Proposed Labeling
• B. Design Controls Activity Summary
• C. 510(k) Summary or 510(k) Statement
• D. Summary of Safety and Effectiveness Data
• [Ans: - D. Summary of Safety and Effectiveness Data]
Explanation: Summary of Safety and Effectiveness Data is not a requirement of a
Special 510(k).
Legal Reference Fragment: Sec. 807.87 Information required in a premarket
notification submission. [...] (j) For submissions claiming substantial equivalence to a
device which ha[s been classified] under section 513(b) of the act: (1) Which was
introduced or delivered for introduction into interstate co[mmerce] for co[mmercial]
distribution before December 1, 1990; and (2) For which no final regulation requiring
premarket approval has been i[ssued...] of the act, a summary of the types of safety and
effectiveness problems a[nd] devices being compared and a citation to the information
upon which th[e summary is based (class III] summary). The 510(k) submitter shall also
,certify that a reasonable searc[h of all information known] or otherwise available about
the class III device and other similar legally [marketed devices has been] conducted
(class III certification), as described in 807.94. This informatio[n shall include any
adverse safety and effectiveness] information that already has been submitted to the
Food and Drug Admi[nistration under] section 519 of the act. FDA may require the
submission of the adverse sa[fety and effectiveness data] described in the class III
summary or citation.
Context Text: Demineralized bone matrix alone (i.e., not combined with another
comp[onent]) meets the four criteria to be regulated solely under Section 361 of the
P[HS Act]. FDA, however, has determined the addition of certain components to DB[M],
[like] calcium phosphates, meets the definition of a device as they are intend[ed to
provide] function of the body by assisting in the filling of bone voids. These DBM
p[roducts are] regulated as devices by CDRH (510(k) clearance required) and as such
mu[st follow the] Quality System Regulation. In addition, the product also needs to
comply [with] 21 CFR 1271 Human Cells, Tissues and Cellular and Tissue-Based
Product[s for the HCT/P] component.
Question: You work for a company that is developing an autologous cellular therap[y.
You tell] your company that its product will be regulated as an HCT/P (Human Cel[ls,
Tissues, and] Tissue-Based Product). Based on this information, with which of the
follo[wing regulatory] requirements will your company need to be compliant when
manufactur[ing it?]
• A. 21 CFR (CGMP requirements for pharmaceuticals)
• B. 21 CFR 1271 and 21 CFR 820
• C. All Subparts of 21 CFR 1271 except Subpart C (Donor Eligibility)
• D. All Subparts of 21 CFR 1271
• [Ans: - C. All Subparts of 21 CFR 1271 exce[pt Subpart C (Donor]
Eligibility)]
Explanation: As the product is regulated under section 361 of the PHS Act, it is only
su[bject to] 21 CFR 1271, with the exception of Subpart C, as autologous products ar[e
exempt from donor] eligibility requirements.
,Clinical Trial Context:
• —Trials of drugs and biologics: controlled clinical investigations, other th[an
those for] a product subject to FDA regulation
• —Trials of devices: (a) a prospective clinical study of health outcomes
co[mpared] with a device, subject to FDA regulation, against a control in human
subj[ects (including] feasibility studies), and (b) pediatric postmarket surveillance
Question: The two mechanisms to amend an OTC Monograph are:
• A. Time & Extent Application (TEA) or Annual Report
• B. Time & Extent Application (TEA) or Citizen Petition
• C. Annual Report or Preapproval Supplement
• D. Citizen Petition or Preapproval Supplement
• [Ans: - B. Time & Extent A[pplication (TEA) or Citizen] Petition]
Question: Which of the following is NOT required in a Biologics License Application
[BLA as compared to a] New Drug Application (NDA)?
• A. FDA form 3397 (user fee cover sheet)
• B. Field copy certification
• C. Chemistry section
• D. Debarment certification
• [Ans: - B. Field copy certification]
Explanation: Field copy certification only applies to NDA products, whereas all of the
o[ther choices are] requirements for both BLAs and NDAs.
Context Text: A treatment IND would be most suitable for this application (answer 1).
T[reatment INDs are intended] as a means of providing eligible subjects with
investigational drugs or bio[logics to treat] serious and life-threatening illnesses for
which there are no suitable alte[rnatives].
Question: You are assigned the task of obtaining an Orphan Drug Designation (ODD[)
for a] drug for new onset Type I diabetes mellitus. Which of the following is NO[T a]
consideration for this ODD application?
• A. The ODD application must be submitted for review to FDA Office of Or[phan
Products] Development (OOPD)
• B. This investigational drug may qualify for ODD as new onset Type I diab[etes is
a] medically plausible disease subset under the Orphan Drug Act
, • C. The ODD application must be submitted electronically to the OOPD t[hrough
the FDA] Submission Gateway (ESG)
• D. The scientific rationale and population prevalence are two areas of the
[application] most critically reviewed by FDA
• [Ans: - C. The ODD application must be su[bmitted to] the OOPD through
the FDA Electronic Submission Gateway (ESG)]
Explanation: Sponsors may send the submission directly to OOPD on physical media
with a sign[ed cover] letter.
Question: How many days does FDA have to review an Abbreviated 510(k)?
• A. 30 days
• B. 60 days
• C. 90 days
1. Which of the following must be submitted to FDA before
conducting a clinical investigation of a significant risk medical
device in the United States?
A. PMA
B. IDE
C. 510(k)
D. De Novo request
[Correct Ans - B. IDE]
Explanation:
An Investigational Device Exemption (IDE) is required to conduct a clinical study of a
significant risk device in order to collect safety and effectiveness data.
2. A 510(k) submission is based on a claim that a new device is:
A. Safe and effective
B. Identical to all marketed devices
C. Substantially equivalent to a legally marketed predicate device
