Looking to Accelerate Medical Device Development, FDA Unveils New Qualification Process

Posted 13 November 2013 | By Alexander Gaffney, RAC 

A new draft guidance document published by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) illustrates a voluntary process by which companies can qualify medical device development tools (MDDT) for use during the development and evaluation of their products.


Regulators have long been interested in making sure that tools and measures used during the 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 or is imprecise in its measurements.

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.

FDA's new draft guidance, Medical Device Development Tools, says regulators have four specific goals in mind for the MMDT process:

  • enabling faster and more efficient development of devices
  • promoting the development of new MDDTs
  • leveraging advances in regulatory science into new MDDTs
  • better communicating to stakeholders which MDDTs are appropriate for use in development programs.

Qualification Policy

The new process represents a marked change over existing policy, CDRH 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." Under the new policy, the qualification process will allow the tools to 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.

Qualification Questions

In general, however, FDA said it will seek to determine the qualification of a proposed MDDT through some common questions:

  • Is the MDDT adequately described?
  • Is the context of use adequately and appropriately defined?
  • Does the available scientific evidence demonstrate that the MDDT reliably and accurately measures what it is intended to measure, is scientifically plausible, and is "reasonably likely" to predict the outcome of interest?
  • Within the specified context of use and given the available strength of evidence, do the advantages of using the MDDT outweigh potential disadvantages of making decisions based on measurements obtained using the MDDT?

FDA's assessment process will also take into account advantages and risks of using the tool, the size and likelihood of any advantages or risks, ways to mitigate risks, the degree to which they are certain of their conclusions, and an assessment of the novelty of the technology.

CDRH said that it intends to prioritize its review of MDDTs according to public health need factors and the scope of the proposed tool's impact, though timelines were not given for anticipated review times. Regulators added that after an initial qualification, additional contexts could then be added to the original application as well.

FDA also said that it will review tools without regard to potential patent use restrictions, as it does not have the resources to review them. Further, FDA said it "may seek external expertise or public comment" in reviewing proposed MDDTs.

Sponsors of MDDTs will be sent a letter informing them of the final qualification status of their MDDT, FDA said.

Comments on the draft guidance are due in 90 days.

Medical Device Development Tools

Federal Register

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