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U.S. Department of Health and Human Services

Medical Devices

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Standard Operating Procedures Review of Investigational Device Exemption (IDE) Application-Specific Issues


CENTER FOR DEVICES AND RADIOLOGICAL HEALTH OFFICE OF DEVICE EVALUATION
and
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH
Standard Operating Procedures
Review of Investigational Device Exemption (IDE)
Application-Specific Issues


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  1. Purpose
  2. Background
  3. Policy
  4. Scope
  5. Roles, Responsibilities and Procedures
  6. Change Control Table

1. Purpose

The purpose of this document is to describe the process for initiating Clinical Trial Director1 review and collaboration to resolve Investigational Device Exemption (IDE) application-specific issues that persist after multiple review cycles.

2. Background

Part of CDRH’s vision includes that patients in the U.S. have access to high quality, safe, and effective medical devices of public health importance first in the world.  To that end, CDRH has identified as a strategic priority the strengthening and streamlining of the clinical trial enterprise so that medical device clinical trials are conducted in the U.S. in a timely, efficient, and cost-effective manner, while maintaining appropriate patient protections.  Review of IDEs is challenging given the short review timeline and the significant clinical, statistical, scientific and engineering expertise necessary to make decisions on the approvability of a study.  CDRH seeks to develop processes to improve efficiency, consistency, and predictability of the IDE process to reduce the time and number of cycles needed to reach appropriate IDE approval for medical devices in general and for devices of public health importance, in particular.

3. Policy

CDRH typically delegates IDE approvability decisions to the review divisions.  In some instances, however, lingering unresolved issues stall progress on an IDE.  Involvement of the Clinical Trials Director in selected submissions provides an opportunity for an objective review of outstanding issues affecting an IDE. 

CDRH staff is expected to apply this procedure when IDE deficiencies and/or other unresolved issues persist between the Sponsor and review staff despite repeated attempts to resolve them.  Reviewers and managers may also choose to involve the Clinical Trials Director to help address and resolve specific challenges related to IDE review, even when outside the scope of this SOP. 

4. Scope

This SOP applies to any original IDE, new study supplement, or expansion of an existing study from feasibility to pivotal, for which a decision other than full approval is made.  This includes disapprovals and conditional approvals.

4.1. This SOP does not apply to:

4.1.1. Pre-submission (pre-IDE) interactions;

4.1.2. IDE review cycles which result in a full approval decision; or

4.1.3. Formal internal disagreements among CDRH staff which are handled via the existing SOP for Resolution of Internal Differences of Opinion in Regulatory Decision-Making.

5. Roles, Responsibilities and Procedures

Reviewers and Branch and Division managers are responsible for identifying IDEs subject to this SOP.

5.1. Sponsor Teleconference

5.1.1. CDRH review staff should offer sponsors a teleconference to occur within 10 business days following any IDE disapproval decision or any second-round or subsequent conditional approval decision.  The purpose of the teleconference is to clarify CDRH’s reasons for IDE disapproval or conditional approval, but not to review additional information submitted by the Sponsor in response to identified deficiencies or discuss issues unrelated to the deficiencies listed in the letter.  If a sponsor cannot meet during the time(s) proposed by the review team, the meeting should be scheduled as soon as is reasonably possible.  The review staff is responsible for documenting the purpose and content of the teleconference in the administrative record consistent with existing CDRH policy. 

5.2. Second Round (and subsequent) IDE Disapprovals and Conditional Approvals

5.2.1. Within one (1) business day after issuing a second round IDE disapproval or conditional approval letter to the sponsor, the CDRH premarket lead reviewer will send an e-mail to the Clinical Trials Director containing a link to the disapproval or conditional approval letter.  The e-mail should have “IDE [ROUND #] ROUND [DISAPPROVAL or CONDITIONAL APPROVAL] – [file number]” in the subject line and should be cc’d to the branch chief, division director, deputy division director(s), and consulting reviewers/managers.

5.2.2. CDRH review staff should offer sponsors a teleconference (see 5.1.1) and should include the Clinical Trials Director in the 10-day IDE disapproval or conditional approval teleconference.

5.2.3. The Clinical Trials Director will schedule and facilitate an internal meeting with the review team and relevant Branch and Division management to discuss the IDE and the remaining outstanding issues.  This meeting should be conducted prior to the disapproval or conditional approval teleconference with the sponsor.  If the Clinical Trials Director reviews the administrative record and determines an internal meeting is unnecessary, he/she may cancel it at their discretion.

5.3. Third Round (and subsequent) IDE Submissions in Response to Disapproval and Conditional Approval Decisions

5.3.1. The Clinical Trials Director will be notified by email within five (5) business days of receipt on an amendment in response to a second (or subsequent) round disapproval/conditional approval letter.

5.3.2. During the third round (and subsequent) IDE submission reviews, consultants are expected to work interactively with the review team throughout the review cycle, although the written review is not due until 14 calendar days from issuance of the consult request.

5.3.3. At least 5 days prior to issuance of a 3rd round (or subsequent) decision letter to the sponsor, the lead reviewer will notify the Clinical Trials Director and cc: the Office Director notifying them of the Division decision.  The e-mail should have “IDE [ROUND #] ROUND [DECISION] – [file number]” in the subject line.

5.3.4. At their discretion, the Clinical Trials Director may request a meeting with the review team prior to issuance of the letter.

5.4. Documentation and Resolution of IDE Application-Specific Issues

5.4.1. If the Clinical Trials Director and the Division are able to identify a mutually agreeable path forward, then the review Division staff is responsible for documenting the decision and the rationale in the administrative file.

5.4.2. If the Clinical Trials Director and the Division are unable to identify a mutually agreeable path forward on a disapproved or conditionally approved IDE, then the Clinical Trials Director and Division staff are each responsible for documenting their perspectives in the administrative file.  The issue should then be brought to the Office Director for their consideration.

5.4.3. Following review of an issue by the Office Director per 5.4.2, the Clinical Trials Director will summarize in writing the Office Director’s decision, including the interactions with the review team, Division management, and Office management as well as the identified next steps and provide a written memo to be included in the administrative file.  The Office Director and Division Management should co-sign the memo and either indicate their concurrence with its accuracy or identify and correct inaccuracies.

5.4.4. If a decision is made to modify the deficiencies or approval status for an already issued disapproval or conditional approval letter, the Division will prepare a corrected IDE letter.  The corrected IDE letter should reference the original letter and the sponsor should be contacted in advance of issuance of the corrected letter to explain what changes have been made and the reason for the changes.

6. Change Control Table

VERSION # REASON FOR CHANGE Revision  DATE Effective DATE APPROVING OFFICIAL (NAME/TITLE)
1.0 Original January 23, 2014 March 1, 2014 /s/
William H. Maisel, MD, MPH
CDRH Deputy Center Director for Science

1 For the purpose of this SOP, the OIR Chief Medical Officer for IVDs or Radiological Health will serve as the OIR Clinical Trials Director.