Regulatory & Compliance Perspectives
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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.
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Understanding The FDA's New Medical Device Cybersecurity Guidelines
11/20/2023
The FDA cybersecurity requirements for medical “cyber devices” went into effect on Oct. 1, 2023. The FDA has made it clear that it cannot even accept submissions that don’t contain the cybersecurity requirements. This article shares 4 steps to navigate the new requirements.
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How To Make The FDA Happy: 7 Medtech Design Pro Tips For Combination Products
11/16/2023
This article shares pro tips related to usability studies, design controls, and other human factors engineering best practices to make the FDA happy with your combination product.
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The U.S., EU, Or U.K.: Which Medical Device Market Should I Enter First?
11/6/2023
This is a time of major regulatory changes, and for many, it's been difficult to keep up. This article shares a brief overview and comparison of the regulatory frameworks in the U.S., EU, and U.K., along with key considerations to keep in mind when choosing your first market.
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Regulation Of Digital Health Technologies After Unwinding Of Pandemic Guidances
11/1/2023
As a result of COVID-19 pandemic, the FDA loosened restrictions on the oversight of digital health technologies (DHTs), and even began to encourage their use in certain settings. The expiration of the public health emergency means that a few of the relevant DHT guidances may sunset this month (November).
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FDA Releases Q&A Guidance On Human Factors Engineering For Combination Products
10/31/2023
Developing an effective combination product can be easily undone if it is not used correctly, and errors made by patients or clinicians are often a direct result of design limitations. To support the co-packaged design process, the FDA has issued a new guidance document titled Application of Human Factors Engineering Principles for Combination Products: Questions and Answers.
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How Does The New European Batteries Regulation Affect Medical Devices?
10/19/2023
On July 12, 2023, the hotly anticipated new Regulation (EU) 2023/1542 on batteries and waste batteries (“Batteries Regulation”) was adopted. The new regulation replaces the previous Directive 2006/66/EC on batteries and aims at regulating the entire battery life cycle and value chain in an integrated manner. The impact will be felt not only by the usual battery-driven industries but also by manufacturers of battery-powered medical devices and in vitro diagnostic devices.
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SaMD PCCP Implementation Beyond AI/ML: Considerations & Challenges
10/13/2023
This is the third and final installment in a three-part article series on postmarket change controls and implementing a Predetermined Change Control Plan (PCCP) for Class II software as a medical device (SaMD) products beyond artificial intelligence/machine learning (AI/ML).
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FDA's Proposed Laboratory-Developed Tests Rule Raises Many Questions But Provides Few Answers
10/11/2023
The FDA has issued a new proposed rule on laboratory-developed tests (LDTs), expressly defining LDTs as a type of in vitro diagnostic (IVD) device, and subject to device regulations, including registration and listing, premarket review, and more. The FDA is accepting comments on the proposed rule through December 4.
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ML-Powered Medical Devices: 10 Tips For Regulatory Compliance
10/11/2023
This article summarizes the 10 principles in the FDA’s Good Machine Learning Practice for Medical Device Development: Guiding Principles, each of which is critical in developing medical devices powered by machine learning (ML). The author also provides tips for how you can employ them.