How to Put Together an
IDE Application
Clinical Investigator Training Course
Silver Spring, MD
November 9, 2016
Véronique Li
Clinical Trials Program
Center for Devices and Radiological Health
Investigational Device Exemption
• An IDE is a regulatory submission that, when approved, permits clinical
investigation of certain medical devices.
• This investigation is exempt from some regulatory requirements.
• The name “Investigational Device Exemption” stems from this description in
21 CFR 812.1:
“An approved investigational device exemption (IDE) permits a device that otherwise
would be required to comply with a performance standard or to have premarket approval
to be shipped lawfully for the purpose of conducting investigations of that device.”
www.fda.gov
2
Law (Food, Drug & Cosmetic Act)  Regulation
• Code of Federal Regulations (21 CFR):
– Part 812: IDE Regulation
– Part 50: Protection for Human Subjects, Informed Consent (IC) Regulation
– Part 54: Financial Disclosure of Investigators
– Part 56: Institutional Review Boards (IRBs) Regulation
www.fda.gov
3
All Device Investigations
Studies Subject to the
IDE Regulation
Studies Exempt from
the IDE Regulation
SR Investigations NSR Studies
Full Requirements
www.fda.gov
Abbreviated Requirements
4
4
Process
Significant Risk IDEs
Non-Significant Risk IDEs
• Full IDE requirements apply
• Sponsor submits IDE
application to FDA
• FDA approves, approves with
conditions or disapproves IDE
within 30 calendar days
• Sponsor obtains IRB approval
• After both FDA and IRB
approve the investigation,
study can begin
• Sponsor presents protocol to
IRB and a statement why
investigation does not pose
significant risk
• If IRB approves the
investigation as NSR, it can
begin
• Abbreviated IDE requirements
(labeling, IRB, consent,
monitoring, reporting,
prohibition on promotion)
• No IDE submission to FDA
needed
www.fda.gov
5
Required Elements
1.
2.
3.
4.
5.
6.
Name and address of sponsor
Report of prior investigations
Investigational plan
A description of the methods, facilities,
and controls used for the manufacture,
processing, packing, storage, and
installation of device
An example of the agreement to be
signed by the investigators and a list of
names and addresses of all investigators
Certification that all investigators have
signed the agreement, that the list of
investigators includes all investigators
participating in the study, and that the
new investigators will sign the
agreement before being added to the
study
7.
8.
9.
10.
11.
12.
A list of the names, addresses, and
chairpersons of all IRBs that have or will
be asked to review the investigation and
a certification of IRB action concerning
the investigation (when available)
The name and address of any institution
(other than those above) where a part
of the investigation may be conducted
The amount, if any, charged for the
device and an explanation of why sale
does not constitute commercialization
Copies of all labeling for the device
Copies of all informed consent forms
and all related information materials to
be provided to subjects as required by
21 CFR 50
All other relevant information that FDA
requests for review of the IDE
application
IDE Application Administrative Checklist
www.fda.gov
6
FDA Review of the Application
• FDA sends acknowledgment with IDE number
GYYxxxx (e.g. G160001)
• IDE sent to appropriate review division based upon
intended use
• Lead reviewer assembles team of experts to review
the application, engage in interactive review with
sponsor, and make decision with management
concurrence within 30 days
• FDA issues a decision letter to the sponsor
www.fda.gov
7
FDA Decisions
• Approval
– Approves the trial for specified number of sites and subjects
– Enrollment can begin once IRB approval is obtained
• Approval with conditions
– Approves the trial for specified number of sites and subjects
provided conditions (deficiencies) are addressed within 45 days
– Enrollment can begin once IRB approval is obtained
• Disapproval
– Study may not begin
– Deficiencies will be listed
– Sponsor must address deficiencies and obtain FDA approval to
start study
www.fda.gov
8
FDA Decisions for Investigational Device
Exemption Clinical Investigations
• Clarifies FDA’s approach to IDE decisions
• Deficiencies
– Issues which must be addressed before study may proceed
• Study Design Considerations
– Those issues unrelated to subject safety that FDA believes
should be addressed to meet sponsor’s stated goals
• Future Considerations
– Issues that FDA believes the sponsor should consider in
preparing for a marketing application or additional clinical
study but which are not necessary to address stated goals of
the study
www.fda.gov
9
FDA Submissions after Approval
• Amendments
– Any response to a deficiency is an Amendment to the submission for which the
deficiency letter was sent
– Can be submitted to Supplements and Reports as well as the Original IDE
– Common amendment reasons: response to approval with conditions, response to
disapproval
• Supplements
– Generally submitted by a sponsor to request something that requires an FDA
decision
– Common supplement reasons: new study, change in protocol
• Reports
– Used to track all IDE reports
– May not be combined with any other submission
– Common report reasons: annual progress report; semiannual investigator list
10