What are the specific contacts in CDER who can answer my questions?

There are a number of ways to communicate with or get reliable, current, and up-to-date information from the Center.

The newest, and easiest, method for getting information is the Center's Web Page at http://www.fda.gov/cder.

For more specific or complex drug inquiries, telephone the Drug Information Branch at (301) 827-4573 or send them an electronic mail message at druginfo@cder.fda.gov.

DHHS-FDA Frequently Asked Questions on IDEs

Clinical Investigator

Confidentiality

Early Collaboration

Humanitarian Device Exemption

In Vitro Diagnostic Devices

Institutional Review Board (IRB) Labeling

New Indication for Marketed Device

Waivers

CLINICAL INVESTIGATOR

Can a clinical investigator submit an IDE?

Yes, a clinical investigator can sponsor his/her own study in which case they are considered a sponsor-investigator and must comply with all the responsibilities of both the sponsor and investigator.

Does the clinical investigator need to sign form FDA-1572?

No, this is a form used for drug studies. For device studies, the sponsor should develop an investigators agreement which includes the elements of 21 CFR 812.43(c). The sponsor should have all investigators sign the agreement prior to participating in the study.

CONFIDENTIALITY

Are IDE records released to the public?

FDA will not disclose the existence of an IDE unless:

• FDA determines that the information had been previously disclosed to the public;
• FDA approves a PMA for a device subject to an IDE; or
• a notice of completion of a Product Development Protocol (PDP) is in effect.

EARLY COLLABORATION

Can I receive advice from FDA on pre-clinical testing and/or on my clinical protocol?

Yes. There are numerous guidance documents available from FDA that provides recommendations on the pre-clinical and clinical testing of devices. Additionally, FDA accepts pre-IDE submissions where you can submit information to FDA and receive advice. This may include a pre­clinical testing plan and/or a draft clinical protocol. Additional information on pre-IDE submissions may be found in the documents "Goals and Initiatives for the IDE Program" http://www.fda.gov/cdrh/d951.html and "Pre-IDE Program: Issues and Answers" http://www.fda.gov/cdrh/ode/d99­1.html.

Additionally, there are two types of early collaboration meetings available that are discussed in "Early Collaboration Meetings Under the FDA Modernization Act (FDAMA)

http://www.fda.gov/cdrh/ode/guidance/310.html http:// www.fda.gov/cdrh/ode/guidance/310.pdf

HUMANITARIAN DEVICE EXEMPTION

My device treats a disease in which only a small number of people are affected. Are there any provisions for these types of devices?

Yes. The Safe Medical Devices Act of(SMDA) of 1990 provided for a humanitarian device exemption to encourage the discovery and use of devices that benefit fewer than 40,000 individuals in the U.S. This provision allows the FDA to grant an exemption from the effectiveness requirements of sections 514 (Special Controls) and 515 (Premarket Approval) of the FD&C Act after finding that:

• the device is designed to treat or diagnosis a disease of condition that affects fewer than 4,000 individuals per year in the U.S.;
• the device is not available otherwise, and there is no comparable device available to treat or diagnose the disease or condition; and ·           
• the device will not expose patients to unreasonable or significant risk, and the benefits to health from the use outweigh the risks.

Devices granted an exemption may only be used at facilities that have an established institutional review committee, and the humanitarian use must be approved by the IRB before use begin.

IN VITRO DIAGNOSTIC DEVICES

Do the IDE regulations apply to in vitro diagnostic devices?

Many in vitro diagnostic (IVD) devices are exempt from the IDE regulations. Under section §812.2(c) of the IDE regulation, studies exempt from the IDE regulation include diagnostic devices if the testing:

1)      is noninvasive;

2)      does not require an invasive sampling procedure that presents significant risk;

3)      does not by design or intention introduce energy into a subject; and

4)      is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure; IVD devices that are under study, including IVD devices that are exemptfrom the IDE regulation, must comply with labeling requirements under 21 CFR 809.10(c)(2). One of two statements is required, as applicable for each case: "For Research Use Only. Not for use in diagnostic procedures", or "For Investigational Use Only. The performance characteristics of this product have not been established."

INSTITUTIONAL REVIEW BOARD (IRB)

Studies which are exempt from the requirements of the IDE regulation are not exempt from the requirements for IRB review and approval and the requirements for obtaining informed consent. In addition, IDE exempt studies are not exempt from §812.119, Disqualification of a clinical investigator.

LABELING

Are there special labeling requirements for investigational devices?

Yes. Under §812.5 an investigational device or its immediate package must bear a label with the following information:

• the name and place of business of the manufacturer, packer, or distributor;

• the quantity of contents, if appropriate; and
• the statement, "CAUTION Investigational device. Limited by Federal (or United States) law to investigational use."

The labeling of an investigational device must not contain any false or misleading statements nor imply that the device is safe or effective for the purposes being investigated.

The sponsor should provide detailed information on device labeling in the investigational plan. This information may vary depending on the device and the nature of the study. Product labeling should be sufficient to ensure stability of the test article for the duration of the study (storage

requirements, calibration procedures), bear sufficient directions for proper administration, and detail procedures to follow in the event of patient injury.

NEW INDICATION FOR MARKETED DEVICE

Do IDE regulations apply if the device has already been approved for a different indication for use?

Yes, the clinical study of a new indication for an already marketed device falls under the IDE regulation.

WAIVERS

Can the sponsor get a waiver from certain IDE requirements? Under § 812.10, a sponsor may request FDA to waive any requirement of the IDE regulation. A waiver request with supporting documentation may be submitted as part of an application or separately. FDA may, by letter, grant a waiver of any requirement that is not required by the FD&C Act and that is unnecessary to protect the human subject by providing a letter to the sponsor outlining the waiver.

DHHS-FDA Frequently Asked Questions on Data Safety Monitoring

• Does my research need Data and Safety Monitoring?
• Does my research need a Data and Safety Monitoring Plan?
• Does my research need a Data and Safety Monitoring Board?

Does my research need data and safety monitoring?

45 CFR 46.111(a)(6) states the following requirement for IRB approval of human subjects research: "When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects."

Does my research need a Data and Safety Plan?

The NIH Policy for Data and Safety Monitoring states that all NIH funded clinical trials require a Data and Safety Monitoring Plan and that monitoring should be commensurate with risk. Most NIH

Institutes/Centers have individual Data and Safety Monitoring policies. Click here for the links to I/C-specific policies.

Does my research need a Data and Safety Monitoring Board?

Data and Safety Monitoring Boards (DSMBs) are specifically required for multi-site clinical trials with interventions that entail risk(s) to participants

DSMBs are generally required for Phase III clinical trials A DSMB may be required for Phase I, Phase II or Phase Ill clinical trials if:

• The clinical trial is blinded
• The clinical trial involves high risk intervention(s), or
• The clinical trial includes vulnerable population(s)