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Guidance

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Common Specifications: An Antidote To MDR’s Clinical Evidence ‘Moveable Feast’?

Unpredictable clinical evidence expectations under the new EU medtech regulations can have a chilling effect on even the most established companies, resulting in product withdrawals. Medtech Insight asked a regulatory expert how this crisis can be avoided.

Europe EU

Real Or Fake? FDA Seeks To Clarify The Definitions Of Legitimate Medical Devices And Counterfeit Ones

The 2020 Safeguarding Therapeutics Act added the term “counterfeit devices” to the US FDA’s lexicon, giving the agency the authority to keep them out of the country or even destroy them.

FDA Policy

Combination Product Human Factors Final Guidance In Clearance, OCP Says

The OCP presented its priorities for 2023 and beyond at the RAPS/AFDO Combination Products Summit on 8 November.

Combination Products Guidance Documents

Global Medtech Guidance Tracker: October 2022

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

Guidance Documents Regulation

FDA Updates 'Least Burdensome' Guidance To Match MDUFA V

An updated final guidance document from the US Food and Drug Administration lays out how regulators should structure deficiency letters when asking sponsors for additional information.

Policy Regulation

Australia Proposes New Guidance On Regulating Boundary & Combination Products

The Australian regulator wants to hear stakeholders’ views on proposals to help decide whether a product is a medicine, a medical device or a biological – or none of the above.

Australia Guidance Documents

FDA Takes Aim At Reducing Health Disparities Through Breakthrough Devices Program

Proposed updates to the US FDA’s breakthrough devices program guidance would help to clarify how the program may be applicable to devices that treat and diagnose diseases that disproportionately affect certain populations.

FDA Policy

Guidance On Regulating AI As A Medical Device Not Top 2023 Priority For FDA

The US FDA’s Center for Devices and Radiological Health has posted the guidance documents it plans to focus on in fiscal year 2023, and guidance on regulating AI as a medical device is not first up.

FDA Policy

‘Project Glass Box’ - UK Reveals Roadmap For AI Medtech Regulation

The MHRA recently announced plans to review and reform how medical devices with AI or software components are to be regulated in the UK. Its new roadmap sheds light on how, exactly, it will deliver on these ambitions.

EU Europe

LASIK Comments Show Divided Opinions As FDA Extends Feedback Period

The comment period for a draft guidance document on labeling for LASIK surgery equipment has been extended for another month. Ninety people have already filed comments, representing a wide range of views about the procedure.

Guidance Documents FDA

Final Guidance Docs Outline Best Practices For FDA Postmarket Studies

The agency advises device makers on its recommendations for postmarket surveillance, both when required under a PMA and when conducted under a 522 order.

Post Market Regulation & Studies Policy

Expert: New Guidance May Demand Clinical Decision Support Software Re-Evaluation

Businesses should reevaluate the classification of their clinical decision software based on a new FDA guidance, Kyle Faget of Foley & Lardner LLP tells Medtech Insight.

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