New FDA Guidance Offers Medical Device Makers New Options for Seeking Priority Review of Premarket Submissions and Appealing Adverse Decisions
On May 17, 2013, the U.S. Food and Drug Administration issued new Guidance for Industry describing options available to medical device makers seeking priority review of premarket submissions or appealing adverse decisions by the Center for Devices and Radiological Health (CDRH).
The first Guidance, entitled Priority Review of Premarket Submissions for Devices, describes the agency's plan to grant "priority review" to devices intended to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions.1 To be considered for priority review, manufacturers must demonstrate that the proposed device satisfies one or more of the following criteria:
- the device represents a breakthrough technology that provides a clinically meaningful advantage over existing technology;
- no approved alternative treatment or means of diagnosis exists;
- the device offers significant, clinically meaningful advantages over existing approved alternatives; or
- the availability of the device is in the best interests of patients.
The priority review designation, which allows for designated applications to be "placed at the beginning of the appropriate review queue," is available for all premarket submissions, including premarket notification submissions (510(k)s), and Biologics License Applications and Supplements (BLAs/BLSs) for medical devices regulated under section 351 of the Public Health Service Act.
Time frames for granting priority review vary. For example, FDA says it will decide whether to grant priority review for pre-submission communications and premarket notifications within two weeks. For premarket approvals, the time will be less than 45 days, and for BLAs, a 60-day window will apply. The agency cautions, however, that priority review status does not guarantee accelerated approval of such submissions.
FDA issued a second Guidance, entitled Center for Devices and Radiological Health Appeals Processes, describing formal and informal methods for resolving disagreements over decisions or actions taken by CDRH.2 The five main methods of resolving disputes discussed in the guidance, listed here from least to most formal, are:
- request for supervisory review;
- request to convene the Medical Devices Resolution Panel (DRP);
- filing a petition that requests that the FDA take or refrain from taking an action, to reconsider a decision, or to place in abeyance an action pending further consideration;
- filing a request for a hearing; and
- filing a suit for judicial review.
Before turning to any of these methods, FDA encourages device makers to engage with reviewers directly, or even to turn to the Center Ombudsman, emphasizing that "discussion and agreement" are normally the most efficient means of resolving disputes.
1This guidance supersedes "Expedited Review of Premarket Submissions for Devices," which the agency issued in 2008, and incorporates changes from the Medical Device User Fee Amendments of 2012 (MDUFA III).
2This guidance supersedes "Medical Device Appeals and Complaints: Guidance for Dispute Resolution," dated February 1998, and "Resolving Scientific Disputes Concerning the Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute Resolution Panel," dated July 2001.
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