LINKS TO
21 CFR PART
812--INVESTIGATIONAL DEVICE EXEMPTIONS
812.1(a) Purpose
812.1(b) References
are to 21 CFR, Chapter 1
812.2(a) General
812.2(b) Abbreviated requirements for these investigations
812.2(b)(1) Non significant risk device
investigations
812.2(b)(2) Investigations begun prior to January 19, 1981
812.2(c) Exempted investigations for these devices
812.2(c)(1) A device in commercial distribution before May 28, 1976
812.2(c)(2) Device substantially equivalent to one in distribution
before that date
812.2(c)(3) Noninvasive diagnostic device
812. (c)(4) Device undergoing consumer preference testing
812.2(c)(5) Device for veterinary use
812.2(c)(6) Device for research with laboratory animals
812.2(c)(7) A custom device
812.2(d) Limit
on certain exemptions
812.2(e) Investigations
subject to IND’s
812.3(a) Act
812.3(b) Custom device
812.3(c) FDA
812.3(d) Implant
812.3(e) Institution
812.3(f) Institutional review board
812.3(g) Investigational device
812.3(h) Investigation
812.3(i) Investigator
812.3(j) Monitor
812.3(k)
Noninvasive
812.3(l) Person
812.3(m)
Significant risk device
812.3(n)
Sponsor
812.3(o)
Sponsor-investigator
812.3(p)
Subject
812.3(q)
Termination
812.3(r)
Transitional device
812.3(s)
Unanticipated
adverse device effect
812.5 Labeling of
investigational devices.
812.5(a)
Contents
812.5(b)
Prohibitions
812.5(c)
Animal research
812.7 Prohibition
of promotion and other practices.
812.7(a) Promote
an investigational device
812.7(b) Commercialize an investigational device
812.7(c)
Unduly prolong an investigation
812.7(d) Represent
that an investigational device is safe or effective
812.10(a)
Request
812.10(b)
FDA action
812.10(c)
Effect
of request
812.18 Import and
export requirements
812.18(a)
Imports
812.18(b)
Exports
812.19 Address
for IDE correspondence.
Subpart B—Application and Administrative Action
812.20(a) Submission
812.20(a)(1) Sponsor submits to FDA
812.20(a)(2) FDA must first approve
812.20(a)(3)
Three copies of application to be submitted
812.20(a)(4)
Separate IDE for exception of informed consent under
50.24
812.20(b) Contents
812.20(b)(1) Sponsor
812.20(b)(2) Prior investigations
812.20(b)(3)
Methods, facilities, and controls for manufacture
812.20(b)(4)
Investigator agreements
812.20(b)(5)
Certification of investigators
812.20(b)(6) IRB chairpersons
812.20(b)(7) Institutions
812.20(b)(8) Sale information
812.20(b)(9) Claim for categorical exclusion
812.20(b)(10) Labeling
812.20(b)(11) Consent documents
812.20(b)(12) Other information
812.25(a) Purpose
812.25(b) Protocol
812.25(c) Risk
analysis
812.25(d) Description
of device
812.25(e) Monitoring
procedures.
812.25(f) Labeling
812.25(g) Consent
materials
812.25(h) IRB information
812.25(i) Other
institutions
812.25(j) Additional
records and reports
812.27 Report of
prior investigations.
812.27(a) General
812.27(b) Specific
contents
812.27(b)(1) Bibliography
812.27(b)(2) Summary of unpublished information
812.27(b)(3) Statement of compliance with good laboratory practice
812.30 FDA action
on applications.
812.30(a) Approval
or disapproval
812.30(a)(1) Thirty days for notification of disapproval
812.30(a)(2) Approval of IDE
812.30(b) Grounds
for disapproval or withdrawal
812.30(b)(1) Failure to comply
812.30(b)(2) Untrue statement
812.30(b)(3) Failure to respond to FDA request
812.30(b)(4) Risk or ethical concern
812.30(b)(5) Other inadequacies
812.30(c) Notice
of disapproval or withdrawal
812.30(c)(1) Statement of reasons for disapproval
812.30(c)(2) Statement of reasons for withdrawal
812.35 Supplemental
applications.
812.35(a) Changes
in investigational plan
812.35(a)(1) Changes requiring prior approval
812.35(a)(2) Changes effected for emergency use
812.35(a)(3) Changes effected with notice to FDA within 5 days
812.35(a)(4) Changes submitted in annual report
812.35(b) IRB
approval for new facilities
812.36 Treatment use
of an investigational device.
812.36(a) General
812.36(b) Criteria
812.36(b)(1) Intended for life-threatening disease
812.36(b)(2) No alternative therapy
812.36(b)(3) Approved IDE
812.36(b)(4) Sponsor pursuing approval
812.36(c) Applications
for treatment use
812.36(c)(1) Contents of treatment IDE application
812.36(c)(2) Practitioner is an investigator
812.36(d) FDA
action
812.36(d)(1) Approval within 30 days
812.36(d)(2) Disapproval or withdrawal of approval
812.36(d)(3) Notice
of disapproval or withdrawal
812.36(e) Safeguards
812.36(f) Reporting
requirements
812.38 Confidentiality
of data and information.
812.38(a) Existence
of IDE
812.38(b) Availability
of summaries or data.
812.38(b)(1) FDA will make summary publicly available
812.38(b)(2) Information
not available before approval, FDA
discretion in disclosing
812.38(b)(3) When IDE has not been disclosed, limit to information
to be made available
812.38(b)(4) Disclosure when exception to informed consent will be
used
812.38(c) Reports
of adverse effects
812.38(d) Other
rules
Subpart C—Responsibilities of Sponsors
812.40 General
responsibilities of sponsors.
812.43 Selecting
investigators and monitors.
812.43(a) Selecting
investigators
812.43(b) Control
of device
812.43(c) Obtaining
agreements.
812.43(c)(1) Investigator CV
812.43(c)(2) Investigator’s experience
812.43(c)(3) Prior terminations
812.43(c)(4) Investigator’s commitment
812.43(c)(5) Financial disclosure
812.43(d) Selecting
monitors
812.45 Informing
investigators.
812.46 Monitoring
investigations.
812.46(a) Securing
compliance
812.46(b) Unanticipated
adverse device effects.
812.46(b)(1) Immediate evaluation
812.46(b)(2) Termination if risk is unreasonable
812.46(c) Resumption
of terminated studies
812.47 Emergency
research under Sec. 50.24 of this chapter.
812.47(a) Sponsor
shall monitor progress, submit public disclosures, and
812.47(b) Transmit
IRB disapprovals
Subpart D—IRB Review and Approval
812.60 IRB
composition, duties, and functions.
812.62(a) All
investigations subject to IRB oversight
812.62(b) If no
IRB exists sponsor may apply to FDA directly
812.64 IRB’s
continuing review.
812.66
Significant risk device determinations.
Subpart E—Responsibilities of Investigators
812.100 General
responsibilities of investigators.
812.110 Specific
responsibilities of investigators.
812.110(a) Awaiting
approval
812.110(b) Compliance
812.110(c) Supervising
device use
812.110(d) Financial
disclosure
812.110(e) Disposing
of device
812.119
Disqualification of a clinical investigator.
812.119(a) FDA will
notify investigator with opportunity for response
812.119(b) FDA may
disqualify investigator from receiving investigational devices
812.119(c) Data will
be examined
812.119(d) Notification
or termination of IDE if data is unreliable
812.119(e) FDA may
withdraw approval or rescind clearance
812.119(f) Investigator
may be reinstated
812.140(a) Investigator
records
812.140(a)(1) All correspondence
812.140(a)(2) Records of receipt, use or disposition of device
812.140(a)(3) Each subject’s case history
812.140(a)(4) Protocol and documentation of deviations
812.140(a)(5) Other records
812.140(b) Sponsor
records
812.140(b)(1) All correspondence
812.140(b)(2) Records of shipment and disposition
812.140(b)(3) Signed investigator agreements
812.140(b)(4) Records for non significant risk device
812.140(b)(5) Adverse device effects
812.140(b)(6) Other records
812.140(c) IRB
records
812.140(d) Retention
period
812.140(e) Records
custody
812.145(a) Entry and inspection
812.145(b) Records inspection.
812.145(c) Records identifying subjects