Regulatory & Compliance Perspectives
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Decoding The FDA's Draft Guidance On Computer Software Assurance For Medical Devices & Bio/Pharma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In 2022, the FDA released a draft guidance on computer software assurance that promises to reshape the validation of automated data processing system and quality system software in the pharma/medical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.
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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.