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Guidance

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FDA Updates Guidance On Unique Device Identification Labeling For Class I Devices

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.

FDA Regulation

FDA Finalizes Class II Status For Surgical Staplers

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.

Safety Regulation

MDUFA IV Report: US FDA Needs To Publish Digital Health Guidance

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report found that for the most part the agency has fulfilled its user fee obligations – but one major shortcoming is an unpublished digital health guidance.

Regulation Policy

Global Medtech Guidance Tracker: September 2021

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.

Guidance Documents Regulation

Aggregating Adverse Events Data Should Be Sponsor Responsibility: FDA

The US agency has published a draft guidance outlining investigator and sponsor responsibilities in which it says sponsors are better suited to report aggregated adverse events to regulators.

Clinical Trials FDA

New FDA Guidance Offers Additional Info On eStar Submissions

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.

FDA Guidance Documents

Final Guidance From FDA Maintains Relaxed Restrictions On Face Coverings

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.

FDA Coronavirus COVID-19

Global Medtech Guidance Tracker: August 2021

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.

Guidance Documents Regulation
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