Devices

FDA as Device Auditor and Consultant

Exeed, a medical device consulting firm, says FDA is changing the way it interacts with violative medical device firms to evaluate and help them develop an appropriate plan of corrective action. In a blog post, Exeed says that the agency’s subtle change in its use of Warning Letters is intended to drive appropriate action before reaching the Warning Letter stage.

A CDRH 11/2018 Medical Device Enforcement and Quality Report says FDA staff now review a firm’s responses to an FDA-483 report on inspection observations, provide feedback on proposed corrective action plans, and monitor progress toward remediation. “The result is an increase in the number of untitled letters, which are intended to address violations that do not reach the threshold of regulatory significance as to require a Warning Letter,” the post says. “This approach, along with an increase in the number of regulatory and other meetings, has led to a significant increase in the number of firms found to have corrected observed violations on follow-up inspections.”

Exeed refers to a recent FDA draft guidance, Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments, that it says can help a violative firm develop and implement more effective corrective actions.

“To some, it may seem to create a challenge in maintaining objectivity as the auditor (in this case, FDA) is also attempting to serve as a consultant,” Exeed says. “However, if done right, this has the potential to significantly remove waste from the system and accelerate implementation of more effective corrective actions in the quality management system to avoid repeat observations in future inspections…. A changing mindset at FDA offers a new opportunity for the medical device industry.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome