Posted 14 August 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) is looking for some help from the medical device industry in the hopes of eventually creating a process of faster, more efficient and more predictable approvals.
Regulators have long been interested in making sure that tools and measures used during the medical device development process are validated -- that is, proper for use and fit for purpose within a specific context. Many clinical trials are ultimately scrapped or panned by regulators when it is determined that a measurement tool does not take into account an important variable, is imprecise or is otherwise inadequate for its stated purpose.
So companies and regulators alike have a vested interest in making sure that tools—which include clinical outcome assessments (COAs), biomarker tests (BTs) and nonclinical assessment models (NAMs)—are validated, allowing both to save time and resources in the pursuit of high-quality regulatory reviews.
Focus on Development Tools
In November 2013, FDA released a draft guidance document, Medical Device Development Tools (MDDTs).
The new guidance represented a sea change in policy, FDA explained.
"Previously, if there was interest in using a particular MDDT for multiple products or different clinical settings, each FDA device review team would typically evaluate the data justifying the MDDT use for each product or setting separately," FDA said.
Under the new policy, tools qualified once for one purpose can then be used within that same context in the future, reducing the need for redundant reviews by CDRH.
Crucial to the qualification process will be the tool's "context of use," which FDA defines as "the way the MDDT should be used and the purpose of the use," as well as its limitations. Relevant aspects of context include the device, the stage(s) of development, the role of the MDDT in the process, and its specific use (patient diagnosis, patient selection or as a clinical endpoint). Outside uses may be considered as well on a case-by-case basis, FDA said.
In addition, each MDDT type (COA, BT or NAM) will be subject to a different set of questions by regulators intended to adjudicate the appropriateness of the tool, FDA said.
The agency said the plan would result in faster, more efficient medical device development and promote the creation and qualification of new MDDTs.
New Pilot Program
For now, there's just one catch: The process is voluntary, and is in need of participants.
In a new Federal Register announcement on 14 August 2014, FDA announced that it is seeking participants for the program under a newly created MDDT Pilot Program.
Under the MDDT Pilot Program, FDA says it hopes to gain experience it can then use to "help inform the final guidance document and processes."
"FDA plans to prioritize proposals based on public health need or potential to impact multiple device development programs," the agency explained. "Additionally, for the purposes of the pilot, proposals are expected to be prioritized based on feasibility, timeline, and FDA resources."
FDA clarified that it also will not place any requirements on an MDDT's licensing, cost or access. In other words, even though an MDDT may be qualified by FDA, there's no guarantee it will be free or easily affordable under the plan.
The agency said it plans to accept no more than 15 candidates, who will ideally have MDDTs which are mature, intended to meet a public health need, have the potential to affect many device development programs or are COA/BT/NAM tests.
Federal Register Announcement