Investigational Device Exemptions Reports and Records

UNITED STATES FOOD AND DRUG ADMINISTRATION
Investigational Device Exemptions Reports and Records
21 CFR 812
OMB Control No. 0910-0078
Non-Substantive Change Request for Medical Devices, Investigational Device Exemptions:
The Food and Drug Administration (FDA) requests a non-substantive change to OMB Control
No. 0910-0078, which supports Investigational Device Exemptions (IDEs) Reports and Records
associated with products regulated by FDA’s Center for Devices and Radiological Health
(CDRH). We request the amendment of this ICR to move the applicable ICs from OMB Control
No. 0910-0741 to OMB Control No. 0910-0078.
Background on IDEs (OMB Control No. 0910-0078)
An Investigational Device Exemption (IDE) allows a device, which would otherwise be subject
to provisions of the FD&C Act, such as premarket notification or premarket approval, to be used
in investigations involving human subjects in which the safety and effectiveness of the device is
being studied. The IDE regulation (21 CFR part 812) is designed to encourage the development
of useful medical devices, and allow investigators the maximum freedom possible, without
jeopardizing the health and safety of the public or violating ethical standards.
Background on “Human Subject Protection; Acceptance of Data from Clinical Investigations for
Medical Devices” (OMB Control No. 0910-0741)
In the final rule titled “Human Subject Protection; Acceptance of Data from Clinical
Investigations for Medical Devices” (83 FR 7366; February 21, 2018), FDA amended its
regulations on acceptance of data from clinical investigations for medical devices. Data
submitted from clinical investigations conducted outside the United States intended to support an
IDE application, a 510(k) submission, a request for de novo classification, a PMA application, a
product development protocol (PDP) application, or an HDE application must be from
investigations conducted in accordance with good clinical practice (GCP), which includes
obtaining and documenting the review and approval of the clinical investigation by an
independent ethics committee (IEC) and obtaining and documenting freely given informed
consent of subjects, which includes individuals whose specimens are used in investigations of
medical devices. The final rule updates the criteria for FDA acceptance of data from clinical
investigations conducted outside the United States to help ensure the protection of human
subjects and the quality and integrity of data obtained from these investigations. As part of this
final rule, we also amended the IDE and 510(k) regulations to address the requirements for FDA
acceptance of data from clinical investigations conducted inside the United States. The final rule
provides consistency in FDA requirements for acceptance of data from clinical investigations,
whatever the application or submission type.
While the information collections in the final rule were revisions to approved information
collections, these collections were submitted to OMB as a new information collection request
(assigned OMB control number 0910-0741, “Human Subject Protection; Data Requirements for
Medical Device Related Clinical Investigations”), with the expectation that the approved ICRs

would be amended after the rule is finalized and the collections are due for renewal. So far, the
following ICRs have been approved by OMB to include provisions/ICs related to human subject
protection; data requirements for medical device-related clinical investigations: OMB Control
Nos. 0910-0120 (510(k)), 0910-0231 (PMA, PDP), 0910-0332 (HDE, HUD) and 0910-0844 (De
Novo). This change request for OMB Control No. 0910-0078 is the last of the amendments
related to the final rule. Upon approval of all the amendments, we will request discontinuance of
OMB Control No. 0910-0741, “Human Subject Protection; Data Requirements for Medical
Device Related Clinical Investigations”. The remaining provisions to be moved from 0910-0741
to 0910-0078 appear in the chart below.
Resultant Burden Estimate
We have not changed the burden estimate for these ICs from what is currently approved for
OMB Control No. 0910-0741. Consistent with our estimate in OMB Control No. 0910-0741,
amending OMB Control No. 0910-0078 to include these ICs increases the total burden estimate
by 17,320 hours 1 (15,810 reporting; 1,510 recordkeeping).
We request that the information collections for the following provisions, currently approved in
OMB Control No. 0910-0741, be included in OMB Control No. 0910-0078:
Section 812.27--Report of Prior Investigations
Section 812.27 addresses requirements for IDE applications supported by clinical data.
For clinical investigations conducted in the United States, sponsors will be required to
submit a statement as described in § 812.27(b)(4)(i). For clinical investigations conducted
outside the United States, sponsors will be required to submit the information as
described in § 812.27(b)(4)(ii).
Section 812.28—Acceptance of Data from Clinical Investigations Conducted Outside the
United States
Section 812.28 addresses the requirements for acceptance of foreign clinical data to
support an IDE or a device marketing application or submission. The sponsor or applicant
must submit a statement as described in § 812.28(a)(1); provide a description of the
actions the sponsor or applicant took to ensure that the research conformed to GCP that
includes the information in § 812.28(b)(1) through (b)(12) or a cross-reference to another
section of the application or submission where the information is located; submit requests
for waivers as described in § 812.28(c); and retain records as described in § 812.28(d).
Section 812.140--Records Retention
Section 812.140 addresses record retention requirements for investigators and sponsors.
An investigator or sponsor will be required to maintain records as described in
§ 812.140(d).

1

We note that the burden hour total listed in the ROCIS system for the current approval (conclusion date:
12/30/2019; approved through: 11/30/2022) is incorrect due to a mathematical error in the reporting burden table.
The total burden hours for 0910-0078, currently approved for 45,782, should be 45,783. This error is corrected in the
attached supporting statement, which includes the requested changes.

Activity/ 21 CFR Section

Report of prior investigations;
U.S.--812.27(b)(4)(i)
Report of prior investigations;
outside the U.S.-812.27(b)(4)(ii)
Data from clinical
investigations--812.28(a)(1)
Description regarding GCP-812.28(b)
Waivers--812.28(c)
Total

Activity/ 21 CFR
Section
Records from clinical
investigations
conducted outside the
U.S.--812.28(d)
Retention period-812.140
Total

Dated: May 2021

Table 1.--Estimated Annual Reporting Burden
No. of
No. of
Total Annual
Respondents
Responses per
Responses
Respondent
400
1
400

Average
Burden per
Response

Total
Hours
1

400

100

1

100

0.25

25

1,500

1

1,500

0.25

375

1,500

1

1,500

10

15,000

10

1

10

1

10
15,810

Total
Hours

10

Table 2.--Estimated Annual Recordkeeping Burden
No. of
No. of Records
Total Annual
Recordkeepers
per Recordkeeper
Records
1,500

1

1,500

Average Burden
per
Recordkeeping
1

10

1

10

1

1,500

1,510