Guidance for Industry and Food and Drug Administration Staff

By Effective Medicine  On  In Medical Devices Tagged  

PDF Printer VersionDocument Issued on: May 17, 2013

This document supersedes the following guidance document: Expedited Review of Premarket Submissions for Devices” dated February 29, 2008.

For questions regarding the use or interpretation of this guidance in the review of PMAs, please contact the PMA Staff at (301) 796-5640.

For questions regarding the use or interpretation of this guidance in the review of 510(k)s, including the Evaluation of Automatic Class III Designation classification actions (de novo review), please contact the Premarket Notification (510(k)) Staff at 301-796-5640.

For questions regarding the use or interpretation of this guidance in the review of devices regulated by CBER, please contact CBER’s Office of Communication, Outreach and Development (OCOD) at 1-800-835-4709 or 301-827-1800.

CDRH LogoCBER Logo

U.S. Department of Health and Human Services
Food and Drug Administration

Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

Contains Nonbinding Recommendations

Preface

Public Comment

You may submit written comments and suggestions at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.  Submit electronic comments to www.regulations.gov.

Identify all comments with Docket No. 1998D-0173.  Comments may not be acted upon by the Agency until the document is next revised or updated.

Additional Copies

Additional copies are available from the Internet.  You may also send an e-mail request to [email protected] to receive an electronic copy of the guidance or send a fax request to 301-827-8149 to receive a hard copy.  Please use the document number (108) to identify the guidance you are requesting.

Additional copies of this guidance document are also available from the Center for Biologics Evaluation and Research (CBER) by written request, Office of Communication, Outreach and Development (OCOD) (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, by telephone, 1-800-835-4709 or 301-827-1800, by email, [email protected], or from the Internet at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm.

Table of Contents

  1. Introduction
  2. Scope
  3. Devices Appropriate for Priority Review
  4. Special Considerations
  5. Priority Review:  Its Meaning and Impact
    1. Priority Review Queue.
    2. Impact of Priority Review
  6. Requesting Priority Review
    1. Industry Responsibilities
    2. FDA Responsibilities
    3. FDA Timeframes for Determinations
    4. FDA Administrative Procedures
  7. Priority Review Procedures for FDA
    1. Resource Management
    2. Advisory Panel Review
    3. Public Disclosure

Guidance for Industry and Food and Drug Administration Staff – Priority Review of Premarket Submissions for Devices

1 and corresponding changes in our expedited review policy for premarket approval applications (PMAs),2 premarket reports,3 product development protocols (PDPs), and premarket notification submissions (510(k)s).

The Medical Device User Fee Amendments of 20121 (MDUFA III), amended the Federal Food, Drug, and Cosmetic Act (the FDC Act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2012.  The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the device review process to meet certain performance goals and implement improvements for the medical device review process.

This guidance document incorporates changes set forth in MDUFA III related to priority (formerly expedited) submissions.  Specifically, the terminology “Expedited” is updated to “Priority” to be consistent with Section 515(d)(5) of the FDC Act.  In addition, for the purposes of evaluating performance goals,2 Premarket Approval Application (PMA) cohorts will not be defined by whether or not a PMA has been designated priority; rather PMA cohorts will be defined by whether or not a PMA is taken to an advisory committee panel meeting for review.  The PMAs that receive priority review designation will, however, still be reported in the MDUFA annual performance reports.

FDA’s guidance documents, including this guidance document, do not establish legally enforceable responsibilities.  Instead, guidance documents describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidance documents means that something is suggested or recommended, but not required.

II. Scope

This document has the following purposes: (1) develop a common understanding of the statutory criteria for granting priority review to premarket submissions for medical devices, and (2) outline standard procedures that should be followed to achieve an efficient priority review process.

While Section 515(d)(5) of the FDC Act only applies to PMAs, because of the potential public health importance of devices warranting priority review status, FDA also has applied the priority review criteria to all premarket submissions, including devices evaluated under a protocol development product (PDP), the Evaluation of Automatic Class III Designation process (also known as the “de novo” or “risk based” classification process), premarket notification submissions (510(k)s), and Biologics License Applications and Supplements (BLAs/BLSs) for medical devices regulated under section 351 of the PHS Act.

III. Devices Appropriate for Priority Review

Using the criteria in section 515(d)(5) of the FDC Act, FDA considers a device or a combination product containing a device,3 appropriate for priority review if the device or combination product:

  1. is intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition, and
  2.  meets at least one of the following:
    1. The device represents a breakthrough technology that provides a clinically meaningful advantage over existing technology.  Breakthrough technologies should be demonstrated to lead to a clinical improvement in the treatment or diagnosis of the life-threatening or irreversibly debilitating condition
    2. No approved alternative treatment or means of diagnosis exists.
    3. The device offers significant, clinically meaningful advantages over existing approved alternatives.  The device should provide for a clinically important earlier or more accurate diagnosis or offer important therapeutic advantages in safety and/or effectiveness over existing alternatives.  Such advantages may include demonstrated superiority over current treatments for effects on serious outcomes (e.g., morbidity), ability to provide clinical benefit for those patients unable to tolerate current treatments, or ability to provide a clinical benefit without the serious side effects associated with current treatments.]
    4. The availability of the device is in the best interest of patients.  That is, the device provides a specific public health benefit, or meets the need of a well-defined patient population.  This may also apply to a device that was designed or modified to address an unanticipated serious failure occurring in a critical component of an approved device for which there are no alternatives, or for which alternative treatment would entail substantial risk of morbidity for the patient.

4  If multiple applications for the same type of device offering comparable advantage over existing approved alternatives have been granted priority review, they are reviewed with priority assigned on a first-in-first-reviewed (FIFR) basis for each review cycle.

Furthermore, if one of these applications is approved, the remaining priority applications will retain their priority status until a final decision is rendered.  Any new application filed after the approval or clearance of a device of the same type will not be given a priority status unless covered under Section IV (Special Considerations).

B. Impact of Priority Review

While all device submissions granted priority review status are prioritized by FDA, there is no assurance that a device will receive FDA marketing authorization in a more timely manner when compared with submissions not granted priority status.  The reasons for this outcome are varied, such as that the devices involve new technology or present complex scientific and regulatory issues often warranting more in-depth review; a failure by the manufacturing facility to be prepared for inspection; or a failure of the applicant to provide adequate scientific data in its submission.

In order to benefit from the priority review process, the commitment on behalf of the applicant to resolve all scientific and regulatory issues should match that of FDA.  It will only be through effective communication (i.e., interactive review) and a total commitment to fulfilling all regulatory and scientific requirements that FDA and the applicant can speed market authorization for safe and effective products.5

In addition, FDA strongly recommends that industry sponsors developing a device that might qualify for priority review to submit a Pre-Submission.6

7– When priority review is a consideration during Pre-Submission communications with companies, review divisions should make a prompt determination regarding device eligibility.  Whenever possible, FDA expects the review divisions to make a determination within two (2) weeks of the request for, or discussion of, a particular device’s eligibility for priority review status.
  • 510(k)s and de novo classification actions – The decision to apply priority review status should be made within two (2) weeks from the receipt date of the submission.
  • PMAs – The decision to grant priority review status should be made as early as possible during the 45-day filing review.8 For PMA supplements that are filed upon receipt (e.g., 180-day supplements), the decision should be reached within 30 days of receipt of the submission
  • BLAs and BLSs – the decision to grant priority review status should be made at the IND stage or as early as possible during the filing review9, i.e., within 60 days of receipt of the submission.

    • D. FDA Administrative Procedures

    To document the determination that priority review is appropriate, the division should complete the “Priority Review Checklist” (Attachment 1) specifying the basis for its determination.  A copy of this form, signed by the Division Director, is to be provided to the appropriate Office Director, and the 510(k) or PMA Staff, or in CBER, to the Regulatory Project Manager (RPM).

    The Priority Review Checklist also includes certain information regarding resource utilization.  In completing the form, review divisions should establish:

    • A Review Team – The division should designate a team leader and review team, as well as identify resources from outside the division that may be needed to appropriately prioritize the review; and
    • A Tentative Timeline for Review of the Application – The division should establish a timeline for review.  Each division should use project management techniques to prioritize applications and monitor timeframes.  

    In CDRH, the division will prepare and issue a letter notifying the applicant of the priority review status.  In CBER, the Office should prepare the letter notifying the applicant of the priority review status.  The notification conveying priority review status may be incorporated into other outgoing correspondence between the applicant and FDA (e.g., a response to an IDE or a PMA filing letter).  A copy of the notification letter should be included in the administrative file according to established procedures.

    10  Although FDA generally does not comment on the status of pending applications, it may release publicly disclosable information if it becomes necessary to correct misleading statements made by the applicant.

    At the time of approval or clearance, FDA may provide notice to appropriate media outlets (through FDA’s Press Office) and FDA information sources (CDRH web page, DSMICA, OCOD, etc.) depending on the significance of the approval or clearance.  FDA may make public sufficient information to permit interested parties to monitor the agency’s implementation of the priority review program, with the exception of information related to priority reviews granted for the special considerations described in Section III above.11

    MDUFA Performance Goals and Procedures” (April 18, 2012). (attachment to letter dated July 16, 2012 from Secretary of Health and Human Services Kathleen Sebelius to The Honorable Fred Upton, Chairman, U.S. House of Representatives Committee on Energy Commerce)

    Types of Communication During the Review of Medical Device Submissions.” When final, this document will represent the Agency’s current thinking on this topic.

    Medical Devices: The Pre-Submission Program and Meetings with FDA Staff”. Once final, this document will represent the Agency’s current thinking on this topic. For CBER IND and BLA/BLS submissions for devices, please refer to at CBER’s meeting procedures webpage.

    Guidance for Industry: Advisory Committee Meetings – Preparation and Public Availability of Information Given to Advisory Committee Members”

    1

    1. breakthrough technology [ ]
    2. no approved alternative [ ]
    3. significant clinically meaningful advantage [ ]
    4. in the best interest of patients. [ ]

    3. Are the answers to 1 any one part of 2 a YES response? [ ] If yes, go to 4. If no, skip to 5.

    Priority Review Assessment (check only one)

    4. The application qualifies for priority review status [ ]

    5. The application does not qualify for priority review status [ ]

    Identify review lead reviewer consultants:

    Attach tentative review timeline.

    Signature: __________________________
    Lead reviewer Date

    Signature: __________________________
    Supervisor Date

    Signature: __________________________
    Division Director Date

    1 FDA will verify the applicability of any justification proposed.



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