FDA Importer Guidance for Medical Devices: What it Means to you Going Forward

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The FDA has had many challenges and setbacks in the past few years. From budget cuts to high-level departures, the agency has also faced fury from lawmakers on Capitol Hill over high-profile device, drug and food recalls.

Off the record, current and former FDAers have told us that they know they’ve been understaffed and underfunded in recent years, and that their enforcement capabilities often weren’t up to the task.

Now with a new president and renewed focus on government regulation in Washington, it’s likely pressure from the White House and Capitol Hill will spur the agency to be more active this year and in the next several years, experts say.

In a new white paper from AssurX, you’ll learn why a FDA’s new Good Importer Practices draft guidance is putting the device industry on notice. The white paper explains that the FDA will:

  • Hold those at the top accountable for any import problems for their
  • Expect medical device manufacturers to be vigilant about quality, and;
  • Increase its emphasis on device firms’ catching and correcting mistakes and
  • complaints.

As this new guidance demonstrates, a revitalized FDA today demands that medical device manufacturers to build quality into their products from the very beginning, and to spot procedural problems very early in the product lifecycle.

At its heart, the FDA guidance wants device manufacturers to:

1) Establish procedures for developing corrective action plans, and for taking corrective and preventive actions if non-compliance with a U.S. requirement or a safety concern should arise.

2) Identify and investigate the root cause of non-compliance with U.S. requirements for products they import, or by foreign firms with which they do business.

3) Take steps to remediate and prevent harm from present and future shipments, and to ensure non-compliance and safety problems do not recur.

4) Work with the non-compliant firm to meet U.S. requirements, or stop conducting business with that firm.

“This is part of a broader effort, pushing responsibility for manufacturing on the manufacturer,” says Mark Mansour, an attorney with Bryan Cave LLP in D.C. While the FDA is saying it will inspect and enforce more, manufacturers are counted on as the “first line of defense,” he adds. “Device firms should take this very seriously,” Mansour said.

Request your copy of the FDA Importer Guidance for Medical Devices paper here.

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