CIP ACTUAL UPDATED QUESTIONS AND ANSWERS
SET A+
✔✔Investigational Device Exemption (IDE) - ✔✔Exemptions from certain regulations
found in the Medical Device Amendments that allow shipment of unapproved devices
for use in clinical investigations.
✔✔Significant/Non-Significant Risk Devices - ✔✔Significant 21 CFR 812.3(m): An
investigational medical device that presents a potential for serious risk to the health,
safety or welfare of the subject, and is:
*intended for use as an implant; or
*used to support or sustain life; or
*used to diagnose, cure, mitigate or treat disease.
Non-Significant: An investigational medical device that does not meet the definition of
an SR.
The IRB must review a
sponsor's SR or NSR determination for every investigational medical device study
reviewed and
modify the determination if the IRB disagrees with the sponsor. If FDA has already
made the
SR or NSR determination for the study, the agency's determination is final.
Sponsors of studies using NSR devices must still adhere to abbreviated IDE
requirements at 21 CFR 812.2(b).
✔✔Premarket Approval - ✔✔Process of scientific and regulatory review by the FDA to
ensure the safety and effectiveness of Class III devices before they become FDA
approved.
✔✔Device Classifications - ✔✔Class I Devices
,Considered to be at the lowest level of risk of all medical devices and are therefore
required to comply with the lowest level of regulatory control. Examples of Class I
devices include: elastic bandages, dental floss and enemas.
Class II Devices
Simple devices, though they are considered to be at slightly higher risk than Class I
devices and therefore require more stringent regulatory controls to provide assurance of
their effectiveness and safety. Examples of Class II devices include: condoms,
pregnancy testing kits and powered wheelchairs.
Class III Devices
Class III devices are generally considered to be the most complex devices. They are
also considered to be at the highest risk and therefore require more stringent regulatory
controls to provide assurance of their effectiveness and safety. Examples of Class III
devices include: implantable pacemakers and breast implants.
✔✔Deception in SBER - ✔✔Deception or incomplete disclosure is permitted only when
the researcher documents that an alteration of the usual informed consent requirements
is justified under the criteria presented in the federal regulations at 45 CFR 46.116(d).
Specifically, the IRB must review and document:
1. There is some scientific value and validity to the use of deception;
2. The relative efficacy of alternative procedures was considered in relation to the
proposed use of deception;
3. The deception does not extend to influence potential subjects' willingness to
participate;
4. The possibility of experimentally induced harm, and whether there are sufficient
procedures in place to remove or mitigate such harm through debriefing after study
participation; and
5. The potential of deception to facilitate unwanted and inappropriate invasions of
privacy.
✔✔Engaged in Research - ✔✔Once an activity is determined to involve non-exempt
human subjects research, each institution involved in some aspect of the research must
determine their "engagement" in that research in order to know if certain regulatory
requirements apply to that activity.
In general, an institution is considered engaged in a particular non-exempt human
subjects research project when its employees or agents for the purposes of the
research project obtain: (1) data about the subjects of the research through intervention
or interaction with them; (2) identifiable private information about the subjects of the
research; or (3) the informed consent of human subjects for the research.
Institutions that are engaged in non-exempt human subjects research are required by
45 CFR part 46 to:
*hold or obtain an applicable OHRP-approved FWA [45 CFR 46.103(a)]; and
, *certify to the HHS agency conducting or supporting the research that the research has
been reviewed and approved by an IRB designated in the FWA, and will be subject to
continuing review by an IRB [45 CFR 46.103(b)].
✔✔Expedited Review Categories - ✔✔Research activities that present no more than
minimal risk to human subjects, and involve only procedures listed in one or more of the
following categories, may be reviewed by the IRB through the expedited review
procedure authorized by 45 CFR 46.110 and 21 CFR 56.110:
1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met:
(a) Research on drugs for which an investigational new drug application (21 CFR Part
312) is not required.
(b) Research on medical devices for which (i) an investigational device exemption
application (21 CFR Part 812) is not required; or (ii) the medical device is
cleared/approved for marketing and the medical device is being used in accordance
with its cleared/approved labeling.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as
follows:
(a) from healthy, nonpregnant adults who weigh at least 110 pounds (amounts drawn
may not exceed 550 ml in an 8 week period and collection may not occur more
frequently than 2 times per week); or
(b) from other adults and children, considering the age, weight, and health of the
subjects, the collection procedure, the amount of blood to be collected, and the
frequency with which it will be collected (amount drawn may not exceed the lesser of 50
ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than
2 times per week).
3. Prospective collection of biological specimens for research purposes by noninvasive
means.
4. Collection of data through noninvasive procedures (not involving general anesthesia
or sedation) routinely employed in clinical practice, excluding procedures involving x-
rays or microwaves. Where medical devices are employed, they must be
cleared/approved for marketing.
5. Research involving materials (data, documents, records, or specimens) that have be
✔✔Humanitarian Device Exemption (HDE) - ✔✔A marketing application for an HUD
(Section 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)). An HDE is
exempt from the effectiveness requirements of Sections 514 and 515 of the FD&C Act
and is subject to certain profit and use restrictions.
✔✔Humanitarian Use Device (HUD) - ✔✔A medical device intended to benefit patients
in the treatment or diagnosis of a disease or condition that affects or is manifested in not
more than 8,000 individuals in the United States per year (Section 3052 of the 21st
Century Cures Act (Pub. L. No. 114-255).
✔✔Unanticipated Problem Involving Risks to Subjects or Others (UPIRSO) -
✔✔OHRP/FDA considers unanticipated problems to include any incident, experience,
or outcome that meets all of the following criteria:
SET A+
✔✔Investigational Device Exemption (IDE) - ✔✔Exemptions from certain regulations
found in the Medical Device Amendments that allow shipment of unapproved devices
for use in clinical investigations.
✔✔Significant/Non-Significant Risk Devices - ✔✔Significant 21 CFR 812.3(m): An
investigational medical device that presents a potential for serious risk to the health,
safety or welfare of the subject, and is:
*intended for use as an implant; or
*used to support or sustain life; or
*used to diagnose, cure, mitigate or treat disease.
Non-Significant: An investigational medical device that does not meet the definition of
an SR.
The IRB must review a
sponsor's SR or NSR determination for every investigational medical device study
reviewed and
modify the determination if the IRB disagrees with the sponsor. If FDA has already
made the
SR or NSR determination for the study, the agency's determination is final.
Sponsors of studies using NSR devices must still adhere to abbreviated IDE
requirements at 21 CFR 812.2(b).
✔✔Premarket Approval - ✔✔Process of scientific and regulatory review by the FDA to
ensure the safety and effectiveness of Class III devices before they become FDA
approved.
✔✔Device Classifications - ✔✔Class I Devices
,Considered to be at the lowest level of risk of all medical devices and are therefore
required to comply with the lowest level of regulatory control. Examples of Class I
devices include: elastic bandages, dental floss and enemas.
Class II Devices
Simple devices, though they are considered to be at slightly higher risk than Class I
devices and therefore require more stringent regulatory controls to provide assurance of
their effectiveness and safety. Examples of Class II devices include: condoms,
pregnancy testing kits and powered wheelchairs.
Class III Devices
Class III devices are generally considered to be the most complex devices. They are
also considered to be at the highest risk and therefore require more stringent regulatory
controls to provide assurance of their effectiveness and safety. Examples of Class III
devices include: implantable pacemakers and breast implants.
✔✔Deception in SBER - ✔✔Deception or incomplete disclosure is permitted only when
the researcher documents that an alteration of the usual informed consent requirements
is justified under the criteria presented in the federal regulations at 45 CFR 46.116(d).
Specifically, the IRB must review and document:
1. There is some scientific value and validity to the use of deception;
2. The relative efficacy of alternative procedures was considered in relation to the
proposed use of deception;
3. The deception does not extend to influence potential subjects' willingness to
participate;
4. The possibility of experimentally induced harm, and whether there are sufficient
procedures in place to remove or mitigate such harm through debriefing after study
participation; and
5. The potential of deception to facilitate unwanted and inappropriate invasions of
privacy.
✔✔Engaged in Research - ✔✔Once an activity is determined to involve non-exempt
human subjects research, each institution involved in some aspect of the research must
determine their "engagement" in that research in order to know if certain regulatory
requirements apply to that activity.
In general, an institution is considered engaged in a particular non-exempt human
subjects research project when its employees or agents for the purposes of the
research project obtain: (1) data about the subjects of the research through intervention
or interaction with them; (2) identifiable private information about the subjects of the
research; or (3) the informed consent of human subjects for the research.
Institutions that are engaged in non-exempt human subjects research are required by
45 CFR part 46 to:
*hold or obtain an applicable OHRP-approved FWA [45 CFR 46.103(a)]; and
, *certify to the HHS agency conducting or supporting the research that the research has
been reviewed and approved by an IRB designated in the FWA, and will be subject to
continuing review by an IRB [45 CFR 46.103(b)].
✔✔Expedited Review Categories - ✔✔Research activities that present no more than
minimal risk to human subjects, and involve only procedures listed in one or more of the
following categories, may be reviewed by the IRB through the expedited review
procedure authorized by 45 CFR 46.110 and 21 CFR 56.110:
1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met:
(a) Research on drugs for which an investigational new drug application (21 CFR Part
312) is not required.
(b) Research on medical devices for which (i) an investigational device exemption
application (21 CFR Part 812) is not required; or (ii) the medical device is
cleared/approved for marketing and the medical device is being used in accordance
with its cleared/approved labeling.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as
follows:
(a) from healthy, nonpregnant adults who weigh at least 110 pounds (amounts drawn
may not exceed 550 ml in an 8 week period and collection may not occur more
frequently than 2 times per week); or
(b) from other adults and children, considering the age, weight, and health of the
subjects, the collection procedure, the amount of blood to be collected, and the
frequency with which it will be collected (amount drawn may not exceed the lesser of 50
ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than
2 times per week).
3. Prospective collection of biological specimens for research purposes by noninvasive
means.
4. Collection of data through noninvasive procedures (not involving general anesthesia
or sedation) routinely employed in clinical practice, excluding procedures involving x-
rays or microwaves. Where medical devices are employed, they must be
cleared/approved for marketing.
5. Research involving materials (data, documents, records, or specimens) that have be
✔✔Humanitarian Device Exemption (HDE) - ✔✔A marketing application for an HUD
(Section 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)). An HDE is
exempt from the effectiveness requirements of Sections 514 and 515 of the FD&C Act
and is subject to certain profit and use restrictions.
✔✔Humanitarian Use Device (HUD) - ✔✔A medical device intended to benefit patients
in the treatment or diagnosis of a disease or condition that affects or is manifested in not
more than 8,000 individuals in the United States per year (Section 3052 of the 21st
Century Cures Act (Pub. L. No. 114-255).
✔✔Unanticipated Problem Involving Risks to Subjects or Others (UPIRSO) -
✔✔OHRP/FDA considers unanticipated problems to include any incident, experience,
or outcome that meets all of the following criteria:
