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Guidance

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Global Medtech Guidance Tracker: May 2024

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

International Guidance Documents

Expert: FDA Missed Opportunity For Software In Remanufacturing Guidance

Device attorney Jason Brooke says that the FDA’s recent guidance document on device remanufacturing represents a “missed opportunity” to discuss software.

Guidance Documents Regulation

Q-Sub Guidance Needs Clarity On Informal Meetings And Timelines, Say Commenters

Stakeholders say the US FDA’s Q-sub guidance could use some tweaking, especially for identifying when informal meetings with the agency are more appropriate than formal ones and creating less burdensome timelines.

FDA Guidance Documents

France Consults On Best Practice Guidelines For Decentralized Trials

The CNIL plans to update its data protection methodologies based mostly on the results of a new consultation and the outcome of a pilot in which companies are asked to identify the challenges they have faced when designing trials with decentralized elements.

Clinical Trials Guidance Documents

EMA Answers More Questions For Manufacturers of Drug-Device Combos

Will it be necessary to provide a new medical device notified body opinion when changes are being made to the medicine in an integral drug-device combination product? This is just one of the new topics addressed in an updated Q&A document from the European Medicines Agency.

Europe Approvals

Remanufacturing Guidance Adds Info On Premarket Requirements For Remanufacturers

After clarifying what a remanufactured device is in its 2021 draft guidance, FDA’s final guidance adds information about regulatory requirements for companies whose devices qualify as remanufactured.

Guidance Documents FDA

Global Medtech Guidance Tracker: April 2024

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

Guidance Documents Regulation

Australia Calls For Companion Testing Plans For Drugs Requiring A CDx

An updated guide from the Therapeutic Goods Administration proposes that sponsors of marketing applications for drugs that require companion diagnostics should provide reassurance that Australian patients will have access to at least one IVD that is adequate for companion testing.

Australia Guidance Documents

CDS Final Guidance Draws More Criticism, This Time From Congress

Senator Bill Cassidy says FDA “disregarded” Congressional intent by expanding its authority to regulate clinical decision support software.

FDA Regulation

FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility

The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.

FDA Evaluate Data

Australia Cuts Regulatory Burden Of Product Recalls

The Therapeutic Goods Administration says it has made a series of improvements in areas such as the recall and stakeholder communication process, reporting requirements, and the agency’s guidance materials.

Australia Recalls

Global Medtech Guidance Tracker: March 2024

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

Guidance Documents Regulation

Nearly 50 New And Revised EU MDR and IVDR Guidances In The Pipeline

Want to know if a much-needed official EU medtech regulatory document is in the pipeline? An updated list of guidance and other documents in the making is now available.

EU Europe

News We're Watching: LDT Survey Finds Concern, Abbott Recall, New Q-Sub Guidance

This week, the US Congress advanced legislation that would support better cardiac emergency preparedness in schools; the former CEO of device company Stimwave was convicted on two counts of fraud; and the FDA issued a draft guidance document on the thermal affects of medical devices.

Regulation Recalls

Cybersecurity Guidance Update Lays Out ‘Cyber Device’ Rules

Draft guidance from the US Food and Drug Administration details what the agency wants to see to demonstrate cybersecurity in connected devices during premarket submissions. 

Cybersecurity Guidance Documents

Day 2: IMDRF Guidance Documents In The Works

Discussions during the second day of the 25th session of the International Medical Device Regulators Forum focused on the establishment of working groups to iron out a plethora of issues for international harmonization.

FDA International
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