Regulatory & Compliance Perspectives
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A Structured Approach To Regulatory Information Management Vendor Selection
3/13/2024
Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.
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Notable Public Comments On The FDA’s Proposed Regulation For Laboratory Developed Tests
3/12/2024
The proposed FDA regulation for laboratory developed tests marks a significant step toward the FDA trying to standardize oversight for these diagnostic tools. As the FDA seeks public input, it is a hot topic as stakeholders grapple with the implications of increased regulatory scrutiny, debating its impact on patient access, innovation, and the overall landscape of diagnostic testing in the U.S.
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6 Things Medtech Companies Should Know About The EU’s AI Act
3/4/2024
With the recent publication of the European Union’s long-awaited Artificial Intelligence Act (AI Act), the message to medtech companies is clear: you need to move toward compliance by understanding your AI systems, determining their role under the AI Act, and identifying the specific obligations and implementation strategies that apply.
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New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis
2/29/2024
On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.
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Understanding Australia’s Regulatory Framework For SaMD
2/12/2024
In 2021, Australia's Therapeutic Goods Administration implemented reforms covering a wide range of software, including software as a medical device (SaMD) with the goals of clarifying the scope of regulated software products, introducing new classification rules, and updating the principles governing software-based medical devices.
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Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma
2/6/2024
In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical device industry and to enhance the quality, availability, and safety of medical devices. This article walks through the key elements of the guidance.
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Secure By Design And Default: Compliant Medical Device Development
1/8/2024
The Cybersecurity and Infrastructure Security Agency, National Security Agency, FBI, and international partners issued recommendations for tech manufacturers to ensure product security and, thereby, assist medical device designers and manufacturers in meeting the quality system cybersecurity considerations mandated by the FDA.
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How To Operate In The AI Compliance Vacuum
12/19/2023
The rapid incorporation of AI into healthcare systems raises significant legal compliance concerns, particularly for technology developers, medtech companies, and users. This article focuses on implications from state practice of medicine laws; the FDA’s regulation of medical devices; the HIPAA Privacy Rule; and the recently issued Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.
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Key Regulatory-Fueled Updates On Combination Products As We Enter 2024
12/15/2023
In late November, AFDO/RAPS held their annual Combination Products Summit in Fort Worth, TX. The meeting is co-sponsored by the FDA with heavy involvement from the Office of Combination Products, and its representatives covered several themes on the subject as we prepare to enter 2024.
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WHO’s 6 Principles For An AI Regulatory Framework For Medical Product Development
12/14/2023
In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.