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The US FDA’s most recent guidance revises UDI requirements for class I and unclassified medical devices the agency issued in July. Class I devices categorized as consumer health products will be exempt from some submission requirements.
The US agency reclassified the device from low-risk class I to moderate-risk class II after reviewing tens of thousands of adverse event reports.
Booz Allen Hamilton’s report found that for the most part the agency has fulfilled its user fee obligations – but one major shortcoming is an unpublished digital health guidance.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
The US agency has published a draft guidance outlining investigator and sponsor responsibilities in which it says sponsors are better suited to report aggregated adverse events to regulators.
The US Food and Drug Administration says its guidance for manufacturers seeking premarket clearance is part of the agency’s overall commitment to improve e-submission consistency and enhance the review process.
The US Food and Drug Administration continues to ease up on rules around various types of face protectors and respirators throughout the duration of the COVID-19 pandemic, so long as they do not pose an undue risk to the public health and provide proper labeling.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-nine documents have been posted on the tracker since its last update.
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