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Medical Devices › Clinical Evaluations

Foley Hoag LLP

Fostering More Access to Medical Devices: FDA’s Efforts to Advance Health Equity

Foley Hoag LLP on

On August 5, 2024, FDA’s Center for Devices and Radiological Health (CDRH) published a discussion paper entitled, “Discussion Paper: Health Equity For Medical Devices” (Discussion Paper), to aid in its efforts to advance...more

Venable LLP

Medical Device Update: FDA Publishes Three New Guidance Documents for the 510(k) Premarket Notification Program

Venable LLP on

The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket Notification program for...more

MoFo Life Sciences

EU: In Vitro Diagnostic Regulation Entered Into Force (Part 3 Of 3)

MoFo Life Sciences on

Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more

MoFo Life Sciences

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 4 Of 6)

MoFo Life Sciences on

After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new risk classification regime (in part 3), in this part 4 of our...more

Seyfarth Shaw LLP

FDA Authorizes Synthetic Nasal Swab to Increase COVID-19 Testing

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Late last week, the U.S. Food and Drug Administration (FDA) announced it approved the use of spun synthetic swabs similar to Q-tips for use in testing for COVID-19....more

Smart & Biggar

Rx IP Update - March 2019

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Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more

Smart & Biggar

Final regulations addressing the public release of clinical information now in force

Smart & Biggar on

On March 4, 2019, the final Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) and Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information)...more

Hogan Lovells

The European Parliament adopted a report on the Commission Proposal for a Regulation on Health Technology Assessment

Hogan Lovells on

On 4 October 2018, the European Parliament adopted its Report on the Commission Proposal for a Regulation on Health Technology Assessment (HTA)....more

Smart & Biggar

Rx IP Update - April 2018

Smart & Biggar on

Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

Jones Day

EU Medical Device Regulation 2017/745 and In Vitro Diagnostic Regulation 2017/746, Pharmaceutical & Medical Device Update, Vol....

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Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the Official Journal of the...more

Knobbe Martens

FDA Announces International Draft Guidance for Clinical Evaluation of Software as a Medical Device

Knobbe Martens on

The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD). The draft guidance was prepared by the SaMD Working Group of the...more

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