Posted 17 May 2013
By Alexander Gaffney, RF News Editor
Capping off a week of several long-awaited guidance documents, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released yet another guidance document, this one regarding the priority review of premarket application (PMA) and premarket notification (510(k)) submissions to the agency.
FDA has several programs it uses to accelerate the approval process for medical products. On the pharmaceutical side, it has fast-track, accelerated approval and priority review processes aimed at either increasing review resources, shortening the review period or basing approval on surrogate endpoints. Companies are eligible for more than one program, depending upon their product's characteristics.
Medical devices, however, have fewer options available. One, the "Innovation Pathway," was only launched in February 2011 and is intended primarily for innovative, "cutting-edge technologies." But the other, more prominent pathway is the Priority Review pathway, which FDA uses to (much like its name implies) prioritize a device application, giving it additional review resources and a more expeditious target window for approval.
But how can a company qualify for the priority review question? FDA is glad you asked, releasing final guidance on 17 May 2013 regarding that exact question. The document, Guidance for Industry: Priority Review of Premarket Submissions for Devices, notes that companies that wish to have their products qualify must show that they are intended to "treat or diagnose a life-threatening or irreversibly debilitating disease or condition."
In addition to that qualification, sponsors must also show that their products meet at least one of the following four qualifications:
- 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.
- The availability of the device is in the best interest of patients by way of its benefits to a well-defined patient population.
FDA notes that a fifth, relatively rare consideration also exists for medical devices intended to address a "national security" identified by the US Department of Defense or the US Department of Homeland Security, both of which work to develop countermeasures that sometimes involve medical technologies. A request for a national security-related priority review procedure must be made by either DOD or DHS, FDA wrote.
But more commonly this process will involve devices intended for more common purposes. FDA's guidance goes on to note that sponsors can expect a number of benefits, including being shuffled to the front of the review queue on a first-in, first-reviewed basis relative to other priority applications and a stronger commitment on the part of FDA staff to review the application. While the impact of both is not guaranteed, in practice such changes lead to faster review and approval times in most cases.
Both FDA and industry will be required to meet certain expectations and uphold certain responsibilities. Industry will need to proactively identify a device as meeting the standards for priority review, and will need to make such a request in writing. In some cases, FDA may grant priority status in advance of an application. In such cases, industry should then follow up with a copy of FDA's correspondence for the official file.
In addition, FDA said that "industry should give priority to resolving all scientific and regulatory issues that surface during the review process." In other words, if FDA has made the review of an application a priority, so too should industry.
FDA's responsibilities mostly relate to getting something reviewed according to pre-set timeframes. Pre-submission communications must be returned within two weeks, as should classification actions for 510(k)s and de novo classifications. PMAs, meanwhile, should be determined within 30 days. Biologically-based devices submitted via a biologic licensing application or a biologic licensing supplement should be reviewed for priority review status within 60 days of filing.
Thereafter, FDA will convene a review team and decide on a tentative timeline for the application's review. Most of these applications (with the exception of 510(k)s) will need to undergo review by an advisory panel.
FDA added that FDA review divisions will need to complete a "Priority Review Checklist," which is contained in the guidance and related to the above mandatory selection criteria for priority review.
The guidance may be found here.