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Medical Devices Proposed Amendments

Smart & Biggar

Health Canada proposes amendments to the Medical Devices Regulations to address future public health emergencies

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Health Canada has proposed amendments to the Medical Devices Regulations (Regulations) that would expand the regulatory framework for COVID-19 medical devices to apply to future public health emergencies...more

Smart & Biggar

Consultation open on Health Canada’s proposal on agile licensing for drugs and medical devices

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UPDATE: The consultation period has been extended until April 26, 2023. On December 17, 2022, the proposed amendments to both regulations were published for consultation: Regulations Amending Certain Regulations Made Under...more

Smart & Biggar

Health Canada publishes notice of consultation for proposed amendments to the Medical Devices Regulations

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On January 7, 2022, Health Canada issued a notice of consultation for proposed amendments to the Medical Devices Regulations. The notice of consultation (i) advises of the notice of intent published on December 11, 2021...more

A&O Shearman

European Commission unveils surprise amendment to In Vitro Diagnostics Regulation

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The European Commission has responded to pressure from the medical devices industry and has proposed an amendment to the In Vitro Diagnostics Regulation (“IVDR”, Regulation 2017/746) to introduce amended transitional...more

Smart & Biggar

Proposed amendments to Food and Drug Regulations and Medical Devices Regulations would modernize the regulatory system for...

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On July 31, 2021, the Minister of Health provided notice of proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations. The amendments are planned for spring 2022 and are intended to modernize...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 7th - 8th, New York, NY

The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more

Faegre Drinker Biddle & Reath LLP

FDA issues final rule clarifying its “intended use” regulations for pharmaceuticals and medical devices

The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more

Smart & Biggar

Health Canada – COVID-19 update highlights

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UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more

Arnall Golden Gregory LLP

Senator McCaskill Introduces Bill to Amend Sunshine Law

In June 2018, Senator Claire McCaskill (D-Mo.) introduced the Patient Advocacy Transparency Act of 2018 (the “Act”), which, if adopted, would amend the Physician Payment Sunshine Act (the “Sunshine Law”). ...more

Smart & Biggar

Proposed amendments to Food and Drug Regulations and the Medical Devices Regulations to publicly release clinical data after...

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Following release of a white paper in March, on December 9, 2017, Health Canada released proposed amendments to the Food and Drug Regulations under which “clinical summaries, reports and supporting data of clinical trials...more

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