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After a delayed start, Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the 'Medical Devices Regulations') have applied for some time now, [...]

In Short The Situation: While generative artificial intelligence ('GenAI') has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug [...]

The Turkish Pharmaceuticals and Medical Devices Authority ('TİTCK') recently published the Announcement on Operations Under the Regulation on Testing, Control and Calibration of Medical Devices and the Regulation on Market [...]

The 12th Development Plan 2024-2028 ('Development Plan') and the 2025 Presidential Annual Program ('Program') set the development goals and strategic policies for various sectors in Türkiye. In line with the [...]

The European Commission has opened the floor for a discussion on whether the EU medical devices legislation is effective, efficient, relevant, coherent and valuable. The Commission aims to assess the [...]

Headlines that Matter for Companies and Executives in RegulatedIndustries Seventh Circuit Considers When Legal Marketing Transforms Into Illegal Kickbacks On December 4, the US Court of Appeals for the Seventh [...]

Related Advisories/Arnold & Porter Events: Webinar, FDA's New LDT Rule: What You Need to Know, April 30, 2024. Advisory, FDA Intends To Regulate Many Clinical Labs as Medical Device Manufacturers: [...]

Introduction Welcome to the September 2024 edition of our Life Sciences and Healthcare Newsletter, where we delve into the latest developments shaping the industry. This month, we explore a range [...]

On November 28, 2024, China's National Medical Products Administration (NMPA, 国家药品监督管理局), China's equivalent of the U.S. Food and Drug Administration, issued the Draft Administrative Measures for Management of Medical Representatives [...]

The European Commission ('Commission') has published a Questions & Answers ('Q&A') document on the new obligation to notify interruptions or discontinuations of the supply of medical devices under the Medical [...]

Health Canada is currently soliciting feedback on their proposal to amend the Medical Devices Regulations (Regulations), with the intention of modernizing the import and sale of medical devices. The consultation [...]

'An open foe may prove a curse, but a pretended friend is worse.' When the poet John Gay wrote these words in 1727, the idea of an administrative agency like [...]

In most instances, it is clear if a product will be considered a 'device' under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Sometimes, though, the question of classification [...]

FDA extends the use of predetermined change control plans beyond AI/ML devices The Food and Drug Administration recently issued new draft guidance, Predetermined Change Control Plans for Medical Devices, that [...]

Preemption is one of our favorite topics, not only because it is a powerful defense, but also because the intricacies of preemption and its many flavors make it inherently interesting-at [...]

In Short You must have a New Zealand-based sponsor to sell medical devices. All medical devices must comply with safety and record-keeping requirements. The Consumer Guarantees Act ensures devices meet [...]

On September 12, 2024, the Pharmaceutical and Medical Device System Subcommittee (the 'Subcommittee') of the Japanese Ministry of Health, Labor and Welfare ('MHLW') convened and established a discussion timeline for [...]

When you represent medical device manufacturers in product liability litigation, you will deal with allegations that a device broke or failed because of what it was made from, and you [...]

Key Takeaways The U.S. Food and Drug Administration (FDA) recently published a Discussion Paper which outlines a potential framework for future guidance and regulations regarding the clinical evaluation of medical [...]

On this episode of Non-binding Guidance, hear from Kellie Combs, chair of Ropes & Gray's life sciences regulatory and compliance practice group, and Josh Oyster, a nationally recognized partner in [...]

Lack of Medical Device Regulation certification means some legacy devices could be pulled from the EU market Thousands of medical device manufacturers have not achieved certification of their products under [...]

With the rapid advancement in medtech, medical devices have been made increasingly based on additive manufacturing techniques. According to GlobalData, a leading data and analytics company, 3D printing in medical [...]

The California Supreme Court has recognized a new path for plaintiffs to prove causation in failure-to-warn cases against manufacturers of prescription drugs and medical devices. Under the learned intermediary doctrine, [...]

On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration's final rule concerning the [...]

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter [...]

On May 6, 2024, the Food and Drug Administration (FDA) issued its long-anticipated final rule regulating laboratory developed tests (LDTs). For approximately two decades, the FDA has been signaling its [...]

Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts and sales [...]

The National Agency for Food and Drug Administration and Control (NAFDAC) is the key body in Nigeria regulating the registration of drugs, medical devices, food supplements, and cosmetic products. For [...]

On January 3, 2024, the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) (the 'Amended Regulations') came into force. They were accompanied by new [...]

Background The Drugs, Medical Devices and Cosmetics Bill, 2023 (the 'Drugs Bill') seeks to replace the Drugs and Cosmetics Act, 1940 (the 'Drugs Act') as the law governing the manufacture, [...]

NEW YORK -- The New York Stock Exchange ('NYSE', the 'Exchange') announced today that the staff of NYSE Regulation has determined to commence proceedings to delist the common stock of [...]

Laos' Ministry of Health (MOH) has promulgated a regulation detailing registration and notification protocols for medical devices. Decision on the Registration and Notification of Medical Devices No. 1470/MOH will come [...]

This summer, the U.S. Food and Drug Administration (FDA) issued draft guidance regarding patient-matched guides to orthopedic implants, which are intended to assist in the execution of a pre-surgical plan [...]

On June 2, 2023, the FDA issued its most recent guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The Q-Sub Program is used by [...]

I. Patentability Requirements A. Inventorship/Invention and Priority Dates 1. Reduction to Practice a. Actual 'Sufficiency of the testing required to show an invention worked for its intended purpose is a [...]

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) released a long-awaited procedural notice with comment period (CMS-3421-NC)1 that outlines a proposed Transitional Coverage for Emerging Technologies [...]

1. Enforcement Roundup: FCPA, Crypto, and Anti-Boycott Actions Crypto Asset Company Settles Sanctions Violations for $7.5 million On May 1, the U.S. Department of Foreign Assets Control (OFAC) announced a [...]

Frankfurt: Deutsche Borse has issued the following company announcement: Date and time of the communication: 2023-06-12T16:13:37 Action type: removal Reasons for the action: Effective from: 2023-07-25T00:00:00 Effective to: Ongoing: false [...]

On May 17, 2023, the Federal Trade Commission ('FTC') announced an enforcement action ('Enforcement Action') against Illinois-based Easy Healthcare Corporation ('Easy Healthcare'), which operates the Premom application, for allegedly violating [...]

Introduction In a major boost to the medical devices company sector, the Union Cabinet, chaired by Hon'ble Prime Minister Narendra Modi, has approved the National Medical Devices Policy 2023 (NMDP) [...]

self At BLG's annual medical device webinar on Nov. 28, 2022, BLG product litigators Keegan Boyd, Josiane Brault, Beverley Moore, Edona Vila, and Glenn Zakaib were joined by Lana Varney [...]

Since its enactment in 2017, Public Law No. 115-92 has significantly boosted the availability of medical products that protect and treat military personnel. Designed to overcome the unique challenges posed [...]

The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled 'Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled [...]

In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical devices: draft [...]

On March 27, 2023, the U.S. Food & Drug Administration (FDA) released two final guidance documents to assist with transitioning medical devices: (i) that were subject to certain enforcement policies [...]

The Government of India, recognising the manufacturing disability faced by the medical device sector in India, had in July 2020 issued the Production Linked Scheme for Promoting Domestic Manufacturing of [...]

This issue of McDermott's Healthcare Regulatory Check-Up highlights significant regulatory activity for February 2023. We discuss several criminal and civil enforcement actions that involve Anti-Kickback Statute (AKS) and beneficiary inducement [...]

Regular readers of our Mintz Viewpoints will likely remember that the Consolidated Appropriations Act for 2023, signed into law by President Biden on December 29, 2022, included as one of [...]

On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when Regulation (EU) 2023/607 (the 'Regulation') was published in the Official [...]

On February 27, a federal jury in Minnesota returned a verdict finding that Precision Lens and its co-founder, Paul Ehlen (together, Defendants), violated the Anti-Kickback Statute, and in turn the [...]