Global Medtech Guidance Tracker: February 2022

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

Guidance word in red keyboard buttons

Thirty-six 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 new EU guideline by the Medical Device Coordination Group explaining the roles and responsibilities of...

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Court Orders US FDA To Return Trial Diversity Action Plan Guidance To Website

 
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HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

Global Medtech Guidance Tracker: June 2025

 
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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.

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products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The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products.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The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.

More from Compliance

Warning Letters – June 2025

The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.

Remote Regulatory Assessments Become Swiss Army Knife For US FDA’s Oversight Of Facilities

 

“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.

Court Orders US FDA To Return Trial Diversity Action Plan Guidance To Website

 
• By 

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.