RAC DEVICES ACTUAL EXAM #5 QUESTIONS
WITH VERIFIED ANSWERS
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic
records and electronic signatures)?
A Manually generated timestamped audit trails to record the date and time of operator
entries and actions that create, modify or delete electronic records.
B Validation of systems to ensure accuracy
C Authority checks to ensure that only authorized personell can create, modify or delete
electronic records.
D Establishment of and adherence to written procedures
A.
The quality assurance manager of a small company consisting of 12 employees is the only
internal auditor for the company and has been performing all internal quality system
audits for three years. This does not meet the requirements for performing internal quality
systems audits because
Auditor independence has not been ensured.
You have modified your 510(k)-cleared device with a Special 510(k). In which case would a
Special 510(k) not be appropriate for the device?
You have changed the primary mechanism of action.
Which Premarket Approval Application (PMA) supplements are NOT subject to user fee
exemption?
Real Time Supplement
A medical device company allows its sales force to maintain a product inventory in the
field. The device has an expiration date indicated on its labeling. A sales person notes that
one of his products has expired and contacts the headquarters office for direction. He is
told to return the product to the headquarter office for replacement. The return of this
product is considered as what type of recall?
Not a recall—it is considered normal stock rotation
A medical device company is developing a product with drug, biologic and device
components. The product and indication have not been previously classified by FDA. What
is the most appropriate regulatory pathway?
A Request for Designation (RFD) should be sent to the Office of Combination Products (OCP) at
FDA to determine the primary mode of action (PMOA) and assign the agency with primary
jurisdiction.
, A firm is preparing a 510(k), premarket notification to FDA for an in vitro diagnostic test,
a microhematocrit analyzer that, among other intended uses, can determine the hematocrit
of a blood donor prior to donation of a blood product. The firm should address the 510(k)
submission to:
CBER
Notice of Intent to Revoke license can be issued for the following reason, EXCEPT
A Unable to gain access to the manufacturing plant,
B Licensed product are no longer safe and effective
C Failure to report serious adverse event,
D Manufacturer fails to conform to applicable standards
C
What is the formal early collaboration meeting that was implemented through the Food
and Drug Modernization Act (FDAMA)?
Agreement Meeting
The Agreement Meeting is a formal meeting to agree upon the parameters of the investigational
plan. When a meeting
request is received by FDA, the meeting will be held within 30 days. The agreements made at the
meeting are provided in writing to the sponsor and are binding on FDA. Regulatory Reference:
Early Collaboration Meetings Under the FDA Modernization Act; Final Guidance for Industry
and for CDRH Staff (February 2001).
A US medical device contract manufacturer has customers for whom it manufactures
medical device components (parts) and finished medical devices. To date, all products have
been either parts for Class II medical devices or Class II finished medical devices. The
manager of new business contacts the regulatory manager to assess the impact of a possible
new customer involving a Class III device. What is the first question the regulatory
manager should ask in order to begin assessing the impact of Class III on plant operations?
Is it a component or device that would be manufactured?
The following biological products are regulated by CBER EXCEPT:
A Immunizing toxoids,
B Monoclonal antibodies for in vitro use,
C Monoclonal antibodies for in vivo use,
D Infusion of animal sourced cells into a hum
B
At the completion of a Preapproval Inspection where a deficiency was noted, a meeting is
convened to discuss what document?
Form FDA 483
WITH VERIFIED ANSWERS
Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic
records and electronic signatures)?
A Manually generated timestamped audit trails to record the date and time of operator
entries and actions that create, modify or delete electronic records.
B Validation of systems to ensure accuracy
C Authority checks to ensure that only authorized personell can create, modify or delete
electronic records.
D Establishment of and adherence to written procedures
A.
The quality assurance manager of a small company consisting of 12 employees is the only
internal auditor for the company and has been performing all internal quality system
audits for three years. This does not meet the requirements for performing internal quality
systems audits because
Auditor independence has not been ensured.
You have modified your 510(k)-cleared device with a Special 510(k). In which case would a
Special 510(k) not be appropriate for the device?
You have changed the primary mechanism of action.
Which Premarket Approval Application (PMA) supplements are NOT subject to user fee
exemption?
Real Time Supplement
A medical device company allows its sales force to maintain a product inventory in the
field. The device has an expiration date indicated on its labeling. A sales person notes that
one of his products has expired and contacts the headquarters office for direction. He is
told to return the product to the headquarter office for replacement. The return of this
product is considered as what type of recall?
Not a recall—it is considered normal stock rotation
A medical device company is developing a product with drug, biologic and device
components. The product and indication have not been previously classified by FDA. What
is the most appropriate regulatory pathway?
A Request for Designation (RFD) should be sent to the Office of Combination Products (OCP) at
FDA to determine the primary mode of action (PMOA) and assign the agency with primary
jurisdiction.
, A firm is preparing a 510(k), premarket notification to FDA for an in vitro diagnostic test,
a microhematocrit analyzer that, among other intended uses, can determine the hematocrit
of a blood donor prior to donation of a blood product. The firm should address the 510(k)
submission to:
CBER
Notice of Intent to Revoke license can be issued for the following reason, EXCEPT
A Unable to gain access to the manufacturing plant,
B Licensed product are no longer safe and effective
C Failure to report serious adverse event,
D Manufacturer fails to conform to applicable standards
C
What is the formal early collaboration meeting that was implemented through the Food
and Drug Modernization Act (FDAMA)?
Agreement Meeting
The Agreement Meeting is a formal meeting to agree upon the parameters of the investigational
plan. When a meeting
request is received by FDA, the meeting will be held within 30 days. The agreements made at the
meeting are provided in writing to the sponsor and are binding on FDA. Regulatory Reference:
Early Collaboration Meetings Under the FDA Modernization Act; Final Guidance for Industry
and for CDRH Staff (February 2001).
A US medical device contract manufacturer has customers for whom it manufactures
medical device components (parts) and finished medical devices. To date, all products have
been either parts for Class II medical devices or Class II finished medical devices. The
manager of new business contacts the regulatory manager to assess the impact of a possible
new customer involving a Class III device. What is the first question the regulatory
manager should ask in order to begin assessing the impact of Class III on plant operations?
Is it a component or device that would be manufactured?
The following biological products are regulated by CBER EXCEPT:
A Immunizing toxoids,
B Monoclonal antibodies for in vitro use,
C Monoclonal antibodies for in vivo use,
D Infusion of animal sourced cells into a hum
B
At the completion of a Preapproval Inspection where a deficiency was noted, a meeting is
convened to discuss what document?
Form FDA 483
