Industry None Too Impressed by FDA's New Program For Certain PMA Devices

Posted in Regulatory and Compliance by Arundhati Parmar on April 23, 2014

The FDA announced a new program by which novel, high-risk devices can receive expedited review but the industry appears skeptical.  

The Food and Drug Administration announced Tuesday that the agency was launching a new, expedited review program for novel devices that meet unmet clinical needs.

The new program is not a new pathway to get certain kinds of high risk devices approved, but does represent an effort by the agency to move novel devices through its review process faster. But the medtech industry doesn’t appear to be too impressed.

The program is specifically designed for high-risk devices that would be approved through a premarket approval pathway and not its 510(k) program. 

Here’s what FDA deems necessary to be considered under the expedites access program, from a news release:

The device needs to:

  • Be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition.
  • Have an acceptable data development plan that has been approved by the FDA
  • Represent one of the following:      
    • no approved alternative treatment/diagnostic exists, or
    • a breakthrough technology that provides a clinically meaningful advantage over existing technology, or
    • offers a significant, clinically meaningful advantage over existing approved alternatives, or
    • availability is in the patient’s best interest

The goal is not simply to hasten the review process but also the actual product development time by allowing developers of these devices to begin discussions with the FDA in their pre-clinical stage.

For more information on medtech industry regulation, attend the MD&M East Conference, June 9, New York City.


The agency provided a draft guidance on the program allowing for pubilc comment. Separately it also provided a draft document that provides guidance that “outlines the agency’s current policy on when data can be collected after product approval and what actions are available to the FDA if approval conditions, such as postmarket data collection, are not met.”

The industry’s largest trade association did not appear to be too impressed by the latest move by the agency to foster innovation and move novel devices through the review process faster.

Janet Trunzo, senior executive vice president, technology & regulatory affairs at AdvaMed, in Washington, D.C., responded via email that the group had yet to thoroughly read the draft guidances released, but that “it is important to remember that Congress required FDA to develop an expedited pathway for breakthrough devices under the FDA Modernization Act of 1997, and while the agency has developed guidance and procedures to fulfill this mandate, it has not succeeded in meeting Congress’s intent.”

She noted that the association will look to “see if the new guidance truly creates an expedited pathway for PMA devices so that they are available to patients and physicians in a more timely manner.”

A medical device regulatory attorney in Minneapolis had a much more critical response.

“The concern I have is that FDA continues to spend increasingly larger part of its time with an increasingly smaller base of devices,” said Mark DuVal, of DuVal & Associates. “Senior management and especially Dr. [Jeffrey] Shuren is increasingly being preoccupied with PMA devices and even a subset of PMA devices - devices that meet unmet clinical needs. Expedited review programs for devices with unmet clinical needs is a laudable thing, but expressed as a percentage of devices that get cleared and approved through this agency, it’s a small amount.”

Meanwhile, the 510(k) program which is the program through which the vast majority of devices are cleared through the FDA “is in shambles and the agency continues to morph it into something that was never designed to be due to their conservative, and frankly illegal interpretations” he charged.

The public has 90 days to comment on the draft guidances. 

[Photo Credit: user akindo]

-- By Arundhati Parmar, Senior Editor, MD+DI


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