Global Medtech Guidance Tracker: October 2021

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-nine documents have been posted on the tracker since its last update.

Guidance word in red keyboard buttons

Thirty-nine guidance documents on medical devices and diagnostics issued by regulatory authorities from around the world were added to Medtech Insight’s Guidance Tracker in the past month.

The updated tracker includes a document jointly issued by regulators in the US, Canada and the UK that can inform...

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New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
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The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.

FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers

 

The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.

‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

FDA Outlines Responsibilities For Owners Of Transferred 510(k)s

 
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The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.

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