In June, FDA released a draft guidance intended to clarify the benefit and risk factors they will consider for medical device compliance and enforcement actions that could impact device availability.

The recommendations give insight into appropriate responses to nonconforming product and compliance issues related to diagnostic and therapeutic medical devices, stopping short of premarket review decisions.

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In particular, FDA recommends device companies carefully weigh risk-benefit profiles when taking regulatory actions. Failing to do so may result in “regulatory actions with unintended adverse effects (e.g., shortage of medically necessary devices).”

We’ve summarized the key factors to consider when assessing a device’s benefits and risks below as detailed in the recent draft guidance.

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An analysis of Warning Letters and other FDA communications over the past five years reveals a few key mistakes pharmaceutical, medical device and other regulated companies are making time and time again in relation to supplier quality and validation. 

From poor recordkeeping to a lack of regular, on-going monitoring, FDA’s increased scrutiny over supplier oversight and qualification for manufacturers makes it crucially important to not only be aware of the problems investigators look for, but how to prevent those issues in the first place.

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