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Application
Application
A sponsor of a significant risk device study must submit a
complete IDE application to FDA. There are no preprinted forms for an IDE application;
however, an IDE application must include certain required information. The sponsor must
demonstrate in the application that there is reason to believe that the risks to human
subjects from the proposed investigation are outweighed by the anticipated benefits to
subjects and the importance of the knowledge to be gained, that the investigation is
scientifically sound, and that there is reason to believe that the device as proposed for
use will be effective.
Required Elements
The following information must be included in an IDE application for a
significant risk device investigation. A sponsor cannot begin a significant risk device
investigation until FDA and IRB approval are granted. Three copies of a signed IDE
application are required and the application must include the following in the order
provided (§ 812.20):
- Name and address of sponsor;
Report of prior investigations (§ 812.27);
A report of prior investigations must include reports of all prior clinical, animal, and
laboratory testing of the device. It should be comprehensive and adequate to justify the
proposed investigation.
Specific contents of the report must include:
- a bibliography of all publications, whether adverse or supportive, that are relevant to
an evaluation of the safety and effectiveness of the device;
- copies of all published and unpublished adverse information;
- copies of other significant publications if requested by an IRB or FDA;
- a summary of all other unpublished information (whether adverse or supportive) that is
relevant to an evaluation of the safety and effectiveness of the device; and
- if nonclinical laboratory data are provided, a statement that such studies have been
conducted in compliance with the Good Laboratory Practice (GLP) regulation in 21 CFR Part
58. If the study was not conducted in compliance with the GLP regulation, include a brief
statement of the reason for noncompliance.
Investigational plan (§812.25)
The investigational plan shall include the following items in the following order:
- purpose (the name and intended use of the device and the objectives and duration of the
investigation);
- protocol (a written protocol describing the methodology to be used and an analysis of
the protocol demonstrating its scientific soundness);
- risk analysis (a description and analysis of all increased risks to the research
subjects and how these risks will be minimized; a justification for the investigation; and
a description of the patient population including the number, age, sex, and condition);
- description of this device (a description of each important component, ingredient,
property, and principle of operation of the device and any anticipated changes in the
device during the investigation);
- monitoring procedures (the sponsor's written procedures for monitoring
the investigation and the name and address of each monitor; see "Guideline
for the Monitoring of Clinical Investigations" for a more detailed
discussion); and
- additional records and reports (a description of any records
or reports of the investigation other than those required in Subpart G of the IDE
regulation).
A description of the methods, facilities, and controls used for the
manufacture, processing, packing, storage, and installation of the device;
An example of the agreement to be signed by the investigators and a
list of the names and addresses of all investigators. Information that must be included in
the written agreement are found in § 812.43;
Certification that all investigators have signed the agreement, that
the list of investigators includes all investigators participating in the study, and that
new investigators will sign the agreement before being added to the study.
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;
Please note that an environmental assessment as required under 21 CFR
25.40 or a claim for categorical exclusion under 21 CFR 25.30 or 25.34 is no longer
required. [§25.34(g)];
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,
Protection of Human Subjects; and
Any other relevant information that FDA requests for review of the
IDE application.
Information previously submitted to FDA in accordance with Part 812 may be incorporated by
reference.
Suggested Content For Original IDE Application Cover
Letter
It is recommended that the cover letter include the following
information in the order provided to assist in the administrative processing of the
application.
- Statement that the information provided is an original IDE submission.
- Device Information:
- Sponsor contact information:
- Name
- Address
- Contact Person
- Telephone Number
- Fax
Please note that the sponsor MUST be located in United States [21 CFR 812.18(a)].
- Manufacturer Information:
- Name
- Address
- Contact Person
- Telephone Number
- Fax
- Applicant Information:
If the organization submitting the application is not the sponsor, such as a consultant or
a lawyer, include contact information for the applicant organization or individual.
- Provide the following information, if applicable:
Pre-IDE/Pre-IDE meetings.
Describe any discussions with the FDA reviewing division regarding this device. If a
Pre-IDE was submitted, state the Pre-IDE number and the name of FDA reviewer, if known. If
a Pre-IDE meeting occurred, provide the name of the FDA contact person and a copy of the
meeting minutes.
Waiver Requests.
Identify any requests for waivers and include a justification for the waiver.
- Referenced Files.
Identify any files that are referenced in the IDE application, such as Premarket Approval,
Premarket Notification 510(k), IDE, or device master files. If files were not submitted by
the sponsor, include a letter from the owner of the files that grants FDA permission to
reference the files in its review of the current application.
Suggested Format For IDE Submissions
In order to facilitate FDA's handling of IDE applications, the
following recommendations are offered:
- Use paper with nominal dimensions of 8 1/2" by 11".
- Use at least a 1 1/2" wide left margin to allow for binding into jackets.
- Use 3-hole punched paper to allow for binding into jackets.
- If the submission exceeds 2" in thickness, separate into volumes and identify
volume number.
- Clearly and prominently identify submission as original IDE application or, for
additional submissions to an IDE application, clearly identify the FDA assigned document
number (e.g., G960000) and the reason for the submission (e.g., amendment or supplement)
and the type of submission (e.g., Response to FDA letter; Addition of New Institution,
etc.).
- All copies of each submission must be identical.
- Do not combine IDEs, PMAs and 510(k)s together; they must be separate submissions.
- Unless the IDE sponsor has provided authorization in writing for another person to
submit information on the sponsor's behalf, only the IDE sponsor may amend, supplement, or
submit reports to the IDE.
- Sequentially number the pages, providing a detailed table of contents, and use tabs to
identify each section. This will help to facilitate the review of your submission.
Common Problems With Original IDE Applications
The sponsor should assure that the device, all preclinical testing, and
the investigational plan are described and provide adequate justification for the
initiation of the clinical trial. Submitters should avoid submitting the IDE application
prematurely. There are three common areas that are frequently deficient in IDE
applications.
- Inadequate report of prior investigations
- Inadequate investigational plan
- Inadequate/incomplete design and manufacture
Common deficiencies with report of prior investigations
A report of prior investigations must include reports of all prior
clinical, animal, and laboratory testing of the device. It should be comprehensive and
adequate to justify the proposed investigation.
- Laboratory Studies
- inadequate description of methods
- inadequate or no summary or conclusion
- conclusions not supported by data
- Reports of Animal Studies
- no rationale for animal selection
- no statistical justification for the number of animals selected
- inappropriate duration or follow-up
- failure to address compliance with Good Laboratory Practices for Nonclinical Studies, 21
CFR 58
- Reports of Prior Publications
- incomplete searches
- copies of relevant publications not included
- omission of adverse information
- failure to identify relevant parts or information and to summarize
Common deficiencies with investigational plan
- questionable scientific soundness
- failure to clearly develop or define study objectives
- inadequate description of the protocol
- failure to identify all risks
- failure to develop proper monitoring procedures
Common deficiencies with design and manufacture
Design
Inadequate characterization
or description of the device and its operation due to inadequate or omitted:
- Design/engineering drawing of device
- Rationale for device design
- Device and performance specifications
- Description of materials (including biocompatibility information)
- Description of function - how does device and/or components/subsystems work together to
achieve desired function
- Validation testing for subsystems and main system
Manufacture
Inadequate or missing description
of the controls used to ensure that the devices are produced consistently and as designed.
Suggested Original IDE Application Administrative Checklist
Following is a suggested checklist that submitters may use to ensure
that their original IDE application is administratively complete. The first section is a
screening to determine whether an IDE application is required to be submitted to FDA. The
next section is the information suggested to be included in the cover letter or cover page
of the IDE application. Inclusion of this information should help speed FDA's
administrative processing of the application. The last section is a checklist to ensure
that all the information required by regulation is addressed in the application.
Screening Information - Is an IDE application to FDA necessary?
Is the investigation within the categories
exempt from the IDE regulation under §812.2(c)?
(If yes, stop. IDE application is not required. IRB clearance and informed consent is
recommended; please check institution's policies.) |
Yes/No |
Is this a nonsignificant risk device
investigation?
(If yes, stop. Submission to and approval from FDA is not required for nonsignificant risk
devices. Follow abbreviated requirements (§812.2(b)) including IRB
approval and informed consent.) |
Yes/No |
If the answer to both of these questions is
no, an IDE application must be submitted to FDA and approval must be obtained from both
FDA and the IRB before the study may begin |
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- Checklist for Cover Letter
Element
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Included
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Statement that submission is an original IDE
application. |
Yes/No |
Device Information:
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Yes/No |
Sponsor (must be located in United
States) [§812.18(a)]:
- Name
- Address
- Contact Person
- Telephone Number
- Fax
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Yes/No |
Manufacturer Information
- Name
- Address
- Contact Person
- Telephone Number
- Fax
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Yes/No |
Applicant Information (Note: IDE application
will not be approved without a U.S. sponsor) [§812.18(a)]
- Name
- Address
- Contact Person
- Telephone Number
- Fax
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Yes/No |
If applicable, provide the following
information:
- Pre-IDE submission/Pre-IDE meetings
- Waiver Requests/Justification
- Referenced Files
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Yes/No |
Checklist for an IDE Application
Elements [§812.20(b)]
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Included
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Format for submission:
Table of contents (recommended)
Paginated pages (recommended)
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Yes/No |
Report of Prior Investigations (§
812.27): Are the following items provided and are they comprehensive and
adequate to justify the proposed investigation? |
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- Report of all prior clinical, animal and laboratory testing
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Yes/No |
- Bibliography of all publications, whether adverse or supportive, that are relevant to an
evaluation of the safety and effectiveness of the device
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Yes/No |
- Copies of all published and unpublished adverse information
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Yes/No |
- Summary of all other unpublished information, whether adverse or supportive, that is
relevant to an evaluation of safety and effectiveness of the device
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Yes/No |
- Statement whether nonclinical tests comply with the good laboratory practice (GLP)
regulation in Part 58
If any studies were not conducted in compliance with the
GLP regulation, a brief statement of the reason for the noncompliance must be provided.
Failure or inability to comply with this requirement does not justify failure to provide
information on a relevant nonclinical test study.
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Yes/No |
If any item is not provided, a justification
for its omission must be provided. |
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Investigational Plan (§ 812.25):
Are the following items included, preferably in the following order: |
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Purpose: Are the following clearly defined?
- name and intended use of the device
- objectives of the investigation
- duration of the investigation (specify in months and years)
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Yes/No |
Protocol: Are the following items provided
and adequate?
- a written protocol describing the methodology to be used including:
- objectives, hypothesis to be tested, or question to be answered
- description of the type of trial (i.e., controlled/open, double-blind/single-blind,
etc.)
- detailed description of the conduct of the trial
- description of statistical methods
- case report forms
- an analysis of the protocol demonstrating its scientific soundness
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Yes/No |
Risk Analysis: Are the following items
provided and adequate to determine that the benefit and knowledge to be gained from the
investigation outweigh the risks to the subjects?
- a description and analysis of all increased risks to the research subjects
- the manner in which risks will be minimized
- a justification for the investigation
- a description of patient population, including number, age, sex and condition
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Yes/No |
Description of the Device:
Are the following items provided and adequate?
- a description of each important component, ingredient and property
- the principle of operation of the device
- a description of any anticipated changes in the device during the investigation
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Yes/No |
Monitoring Procedures: Are the
following items present?
- the written procedure for monitoring the investigation
- the name and address of the individual(s) who will monitor the study
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Yes/No |
Manufacturing Information:
[812.20(b)(3)] Is adequate manufacturing information provided to allow a judgement about
the quality control of the device (e.g., that the device will meet the intended
specifications) based on the description of methods, facilities and controls used for:
a. manufacturing
b. processing
c. packing
d. storage
e. installation
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Yes/No |
Investigator Information:
[812.20(b)(4)] Are the following items included? |
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Example of investigator agreement
[see
§ 812.43(c)] which should include:
- the investigator's curriculum vitae;
- where applicable, a statement of the investigator's relevant experience (including the
dates, location, extent and type of experience);
- if the investigator was involved in an investigation or other research that was
terminated, an explanation of the circumstances that led to termination; and
- a statement of the investigator's commitment to:
- conduct the investigation in accordance with the agreement, the investigational plan,
Part 812 and other applicable FDA regulations, and conditions of approval imposed by the
reviewing IRB and FDA;
- supervise all testing of the device involving human subjects; and
- ensure that the requirements for obtaining informed consent are met
- Investigators commitment to provide sufficient and accurate financial disclosure
information and update information if any relevant changes occur during the investigation
and for one year following the completion of the study.
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Yes/No |
Certification that all participating
investigators have signed the agreement and that no investigator will
be added until the agreement is signed. [812.20(b)(5)] |
Yes/No |
Name and address of investigators who have
signed the agreement. |
Yes/No |
IRB Information: Are the
following items included? |
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Name, address, and chairperson of each IRB |
Yes/No |
Certification of the action taken by each
IRB, (i.e., approval letter)
How many IRBs have approved the investigation?
How many IRBs are currently reviewing the investigation or will review it in the
future?
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Yes/No |
Names and addresses of any institutions
(other than those identified above) where a part of the investigation may be conducted |
Yes/No |
Sales Information: [812.7(b)] Is
the following information provided? |
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Is the device to be sold |
Yes/No |
If yes, is the amount to be charged provided |
Yes/No |
Explanation of why sale does not constitute
commercialization |
Yes/No |
§ 812.7(b) prohibits the commercialization
of an investigational device by charging subjects or investigators for a device a price
larger than necessary to recover costs of manufacture, research, development, and
handling. |
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Environmental Impact Assessment:
[§812.20(b)(9)] An environmental impact assessment or a claim for categorial exclusion
is no longer required. [§25.34(g)]
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Labeling: [§812.5] Are copies of all labeling for the device provided and include the
following? |
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Does the labeling contain the statement
"CAUTION-Investigational Device. Limited by Federal (or United States) Law to
Investigational Use." [§ 812.5(a))] |
Yes/No |
Does the labeling contain adequate
information for the purposes of the investigation, in accordance with § 812.5(a),
including the name and place of business of the manufacturer, packer, or distributor, the
quantity of contents, and a description of all relevant contraindications, hazards,
adverse effects, interfering substances or devices, warnings, and precautions? If
any item is not addressed, a justification for its omission must be provided. |
Yes/No |
Note: The device may not be promoted as safe
and effective for the use for which it is being investigated. [§812.7(d)] |
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Informed Consent Materials: [21 CFR
50, 812.25(g)] |
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Are all forms and informational
materials to be presented to the subject included? |
Yes/No |
Does the informed consent form
seek consent from the subject or a legally authorized representative, when appropriate
(e.g., when the subject is a minor)? |
Yes/No |
Does the informed consent form
contain the basic required elements? (see
21 CFR Part 50.25(a))
Required Elements:
- a statement that the study involves research
- an explanation of the purposes of the research
- the expected duration of the subject's participation
- a description of the procedures to be followed
- identification of any procedures which are experimental
- a description of any reasonably foreseeable risks or discomforts to the subject
- a description of any benefits to the subject or others
- a disclosure of appropriate alternative procedures or courses of treatment that might be
advantageous to the subject
- a statement describing the extent to which confidentiality of the subject's records will
be maintained and that FDA may inspect the records
- an explanation as to whether any compensation and/or medical treatments are available if
injury occurs and, if so, what they consist of or sources of further information
- an explanation of whom to contact for answers to questions about the study and the
subject's rights and whom to contact in the event of a research-related injury
- a statement that participation is voluntary and that subjects may refuse to participate
or discontinue participation at any time without penalty or loss of benefits
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Yes/No |
Additional Elements Required When Justified:
- A statement that the procedure or treatment may involve unforeseeable risks to subject,
or to the embryo or fetus if the subject were to become pregnant
- Anticipated circumstances under which the investigator may terminate the subject's
participation without regard to the subject's consent
- Any additional costs to subject as a result of participation
- Consequences of a subject's decision to withdraw and procedures for withdrawal
- A statement that significant new findings which may relate to the subject's willingness
to participate will be provided to the subjects
- The approximate number of subjects involved in the study
- Does the consent process involve a "short form"
written consent [21 CFR Part 50.27(b)(2))]. If yes, a copy of the "short form"
and a written summary of what is to be said to the subject or representative should be
provided.
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Yes/No/NA |
The informed consent form may not contain
exculpatory language [21 CFR Part 50.20] |
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Other Information: Provide
additional information supportive of the investigation and any information FDA has
identified (through previous contact with the agency or through guidance documents) as
required.
If any item is not provided, a justification for its omission must be provided. |
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Address for IDE Applications
Sponsors of a significant risk device investigation must submit three
copies of a signed "Application for Investigational Device Exemption." That is,
the cover page of your application should identify the submission as an application for
investigational device exemption and the page should be signed by the sponsor. There are
no IDE application forms. Mail the cover page and accompanying materials to the following
address:
Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center (HFZ-401)
9200 Corporate Boulevard
Rockville, Maryland 20850-3223
All correspondence relating to an IDE should also be sent to this address. The IDE correspondence should be submitted in triplicate
and reference the IDE number.
The outside wrapper of each submission
should identify the contents, for example, "IDE Application," "Supplemental
IDE," "Waiver," etc.
IDE Modifications
Changes in investigational plan that require prior approval (§ 812.35)
A sponsor must obtain approval of a supplemental application
and IRB approval (when appropriate under conditions described in §56.110 and
§56.111 prior to implementing a change to an investigational plan except in
situations described below. If a sponsor intends to conduct an investigation
that involves an exception to informed consent under §50.24 (see
Informed Consent), the sponsor must submit a separate investigational
device exemption (IDE) application [§812.20(a)].
FDA believes that the following types of protocol changes would
require an approved IDE supplement because they are likely to have a significant
effect on the scientific soundness of the trial design and/ or validity of the
data resulting from the trial:
- change in indication,
- change in type or nature of study control,
- change in primary endpoint,
- change in method of statistical evaluation, and
- early termination of the study (except for reasons related to patient safety).
In addition, FDA believes that expanding the study by increasing
either the number of investigational sites or the number of study subjects participating
in a clinical investigation affects the rights, safety, and welfare of the subjects.
Therefore, the study may not be expanded without submission and approval of
an IDE supplement.
The IDE supplement should be identified with the IDE number
on the cover sheet and submitted in triplicate. The outside wrapper of the submission
should identify the contents as "Supplemental IDE."
Changes that do not require prior FDA approval.
The sponsor of an IDE may modify the device and/or clinical
protocol without approval of a new application or supplemental applications
if the modifications meet certain criteria. The notice must be provided to FDA
within 5 working days of making the change.
- Emergency Use.
FDA approval of a supplement does not apply in the case
of a deviation from the investigational plan to protect the life or physical
well-being of a subject in an emergency. However, such deviation must be
reported to FDA within 5-working days after the sponsor learns of it [§812.150(a)(4)].
Additional information can be found in "Guidance on IDE Policies and
Procedures"
http://www.fda.gov/cdrh/ode/idepolcy.html
http://www.fda.gov/cdrh/ode/idepolcy.pdf
- Certain Developmental Changes.
Criteria
An FDA approved supplement is not required for developmental
changes in the device (including manufacturing changes) that do not constitute
a significant change in design or basic principles of operation and that
are made in response to information gathered during the course of an investigation.
This determination is made by the sponsor and must be based on credible
information. Credible information to support developmental changes in the
device (including manufacturing changes) includes data generated under the
design control procedures of §820.30 (See
Design Controls), preclinical/animal testing, peer reviewed published
literature, or other reliable information such as clinical information gathered
during a trial or marketing. The sponsor must provide notice to FDA within
5-working days of making these changes.
Generic types of device and manufacturing changes include
changes to the control mechanism, principle of operation, energy type, environmental
specifications, performance specifications, ergonomics of patient-user interface,
dimensional specifications, software or firmware, packaging or expiration
dating, sterilization, and the manufacturing process (including the manufacturing
site). Sponsors may refer to ``Deciding When to Submit a 510(k) for a Change
to an Existing Device'' for assistance in identifying the types of changes
which may qualify for implementation under this provision. Any specific
change within a particular type may or may not be appropriate under the
5-day notice provision because changes in each of these categories could
range from minor to significant depending upon the particular device, the
type of modification, and the extent of the modification. The impact of
the change would still need to be determined by information generated by
design controls or other appropriate means to assess the significance of
the change to the device design or manufacturing process and the appropriateness
of a 5-day notice submission.
Please note that all developmental changes need to be reported
to the IRB in the sponsors annual report. In addition, the changes
may be subject to IRB review procedures under 21 CFR 56.110.
All changes to the basic principles of operation of a device
are considered to be significant changes that should be submitted in an
IDE supplement.
5-day Notice
The sponsor must submit a notice of the change to the IDE
no later than 5-working days after making the change. Changes to devices
are deemed to occur on the date the device, manufactured incorporating the
design or manufacturing change, is distributed to the investigator(s). These
notices must be identified as a ``notice of IDE change.''
For a developmental or manufacturing change to the device,
the notice must include a summary of the relevant information gathered during
the course of the investigation upon which the change was based; a description
of the change to the device or manufacturing process (cross-referenced to
the appropriate sections of the original device description or manufacturing
process); and, if design controls were used to assess the change, a statement
that no new risks were identified by appropriate risk analysis and that
the verification and validation testing, as appropriate, demonstrated that
the design outputs met the design input requirements. If another method
of assessment was used, the notice must include a summary of the information
which served as the credible information supporting the change. FDA will
only notify the sponsor if questions arise or additional information is
needed.
- Certain changes to the clinical protocol.
Criteria
An FDA approved supplement is not required for changes
to clinical protocols that do not affect:
- The validity of the data or information in the approved protocol, or
the patient risk to benefit relationship relied upon to approve the protocol;
- The scientific soundness of the investigational plan; or
- The rights, safety, or welfare of the human subjects involved in the
investigation.
This determination is made by the sponsor and must be based
on credible information. Credible information to support changes to clinical
protocols is defined as the sponsor's documentation supporting the conclusion
that a change does not have a significant impact on the study design or
planned statistical analysis, and that the change does not affect the rights,
safety, or welfare of the subjects. Documentation must include information
such as peer reviewed published literature, the recommendation of the clinical
investigator(s), and/or the data gathered during the clinical trial or marketing.
The sponsor must provide notice to FDA within 5-working days of making these
changes.
Examples of these types of changes may include the following changes:
- Modification of inclusion/exclusion criteria to better define the target
patient population
- Increasing the frequency at which data or information is gathered
- Inclusion of additional patient observations or measurements
- Modifying the secondary endpoints (Secondary endpoints usually support
a secondary labeling claim that the sponsor wants to make for the device
and are not used to determine the safety or effectiveness of the device.)
5-day Notice
The sponsor must submit a notice of the change to the IDE
no later than 5-working days after making the change. Changes to a clinical
protocol are deemed to occur when a clinical investigator is notified by
the sponsor that the change should be implemented in the protocol or, for
sponsor-investigator studies, when a sponsor-investigator incorporates the
change in the protocol. These notices must be identified as a ``notice of
IDE change.''
For a protocol change, the notice must include a description
of the change (cross-referenced to the appropriate sections of the original
protocol); an assessment supporting the conclusion that the change does
not have a significant impact on the study design or planned statistical
analysis; and a summary of the information that served as the credible information
supporting the sponsor's determination that the change does not affect the
rights, safety, or welfare of the subjects. FDA will only notify the sponsor
if questions arise or additional information is needed.
Changes to be submitted in the annual report.
Minor changes in the following areas:
- the purpose of the study,
- risk analysis,
- monitoring procedures,
- labeling,
- informed consent materials, and
- IRB information
may be reported in the annual progress report for the IDE if
the changes do not affect: (i) The validity of the data or information resulting
from the completion of the approved protocol, or the relationship of likely
patient risk to benefit relied upon to approve the protocol; (ii) The scientific
soundness of the investigational plan; or (iii) The rights, safety, or welfare
of the human subjects involved in the investigation [812.150(b)(5)]. If
the changes do affect the above criteria, then prior approval must be obtained.
IDE supplements for new facilities
FDA will review initial IDE applications that do not contain
a certification of IRB approval for each site. FDA may approve the investigational
sites without IRB approval. The sponsor is required to submit the certification
in an IDE supplement when he obtains IRB approval. If the site is already approved
and the supplement is just the certification of IRB approval, FDA usually does
not provide a written response to the certification since the site has previously
been approved by FDA.
If the sponsor has determined the number of investigational
sites for the study but not yet identified all the sites at the time the IDE
is submitted, FDA may grant a waiver to the sponsor. The waiver would allow
the sponsor to enroll the sites, obtain IRB approvals, and then submit all the
certifications of IRB approval to FDA at one time (or at 6 month intervals if
it takes that long to enroll the sites) instead of requesting each site as it
is identified.
Once the IDE is approved, the sponsor may submit an IDE supplement
to request approval of additional clinical study sites. FDA will respond in
writing to the supplement approving or denying the request. The sponsor is required
to submit;
- Identification of the investigational site,
- certification of IRB approval,
- information updating the initial IDE application (if the investigation is
changed), and
- a description of any modifications required by the IRB as conditions of
approval.
Certification of IRB approval for a new sites does not need
to be included in the request but the sponsor will need to submit it to us once
he has IRB approval.
The sponsor may not begin any part of the investigation at an institution until:
- IRB approval is obtained;
- FDA receives certification of IRB approval; and
- FDA approves the supplemental application.
Additional information can be
found in the following guidance document.
Changes or Modifications During the Conduct of a Clinical
Investigation
http://www.fda.gov/cdrh/ode/guidance/1337.html
http://www.fda.gov/cdrh/ode/guidance/1337.pdf
References:
Last modified
dateJuly 21, 2003
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