Posted 06 February 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration's (FDA) device regulatory division, the Center for Devices and Radiological Health (CDRH), has released a document outlining its strategic priorities over the next year, highlighting a focus on several topics long sought after by members of industry, including an accelerated approval pathway for some devices.
The document, CDRH 2014 Strategic Priorities, sets three priorities for CDRH at its outset:
- strengthen the clinical trials enterprise
- strike the right balance between premarket and postmarket data collection
- provide excellent customer service
"By addressing these priorities over the next two years, we hope to help medical device developers choose the US as the country of first choice for their technologies," CDRH wrote. "The country of first choice is a key contributor to early patient access to high-quality, safe and effective devices."
CDRH has been beleaguered by criticism in recent years that its approvals lag behind those of other countries, and particularly those in Europe, which use a notified body system with in-country regulatory oversight.
CDRH's explicit acknowledgement of this problem at the outset of the strategic priorities document would seem to indicate that it's ready to devote significant resources to the problem above and beyond prior efforts.
Strengthening, Accelerating Trials
Key to that strategy is its first priority, strengthening the clinical trials enterprise. CDRH writes that it wants to strengthen and streamline clinical trials such that they become more efficient and cost effective while maintaining "appropriate patient protections."
To do this, it's hoping some of its earlier efforts start to bear results in 2014: A 2012 draft guidance on early feasibility studies, a new voluntary submission process for investigational devices, and a guidance on benefit-risk determinations in premarket applications. Already, these efforts have increased two-cycle approvals from 46% in 2011 to 77% in 2013, FDA said. During the same period, the median time to full study approval dropped from 435 days to just 174.
In the coming year, CDRH said it hopes to reduce by 25% the number of devices requiring three or more cycles to obtain an approval decision for an investigational device exemption (IDE), and by 50% by July 2015.
All sponsors of IDE applications that were not approved will also be offered a teleconference or in-person meeting with FDA within 10 business days of FDA's decision to discuss remediation and next steps.
FDA has also set of a goal of increasing the number of early feasibility and first-in-human IDE studies submitted to each and every CDRH review division relative to FY 2013 by July 2015. To do so, it says it will establish a new "premarket clinical trials program" in its Office of Device Evaluation to oversee the performance of the IDE Program and development and implementation of new policies.
That same office will also formally incorporate patient-specific factors into the IDE process, potentially making it less risk-averse, CDRH said.
Faster Approvals and an Accelerated Approval Pathway
CDRH's second priority, striking a balance of when to collect safety data, implied that CDRH may be more amicable to shifting some of its premarket data collection burdens to postmarket settings in the coming year. "[O]ur data requirements impact when U.S. patients have access to a device," it noted. "This makes it critical that we strike the right balance between premarket and postmarket data collection."
"Specifically, striking the right balance between premarket and postmarket data means balancing the possible benefits of earlier patient access to the device especially when the alternatives are either absent or of limited use and the possible risks of patient harm from exposure to an unsafe or ineffective device," the document continues.
CDRH noted that several of its projects-The National Medical Device Postmarket Surveillance System, the Case for Quality Initiative, its participation with the International Medical Device Regulators Forum (IMDRF) and its Medical Device Single Audit Program (MDSAP)-could make it easier for it to accept less evidence in support of an approval.
Accordingly, CDRH says it plans to review 50% of all device types subject to a PMA (i.e. Class III medical device classifications) to determine if some premarket data requirements may be shifted to the postmarket. This review will occur by the end of 2014, it said. That review will include 100% of Class III device types by the end of 2015.
It also plans to develop and publish a draft framework on how to shift those requirements and when it is appropriate to do so. Other changes will include a retrospective review of all PMA device types to see if down-classifications would be appropriate and a new "mechanism to prospectively assure the appropriate balance of premarket and postmarket data requirements for new devices subject to a PMA."
But perhaps most important of all, CDRH said it is investigating using its "Existing authorities" to establish a new approval pathway for devices that meet an "unmet public health need by shifting appropriate premarket data needs to the postmarket," similar to FDA's accelerated approval pathway for pharmaceutical products.
CDRH 2014 Strategic Priorities