Regulatory & Compliance Perspectives
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The 8 Key Takeaways For FDA Inspections In The Food And Drug Omnibus Reform Act
2/7/2023
With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on Dec. 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and more.
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3 Lessons U.S. Healthtech Companies Can Learn From The Cerebral Investigations
2/6/2023
Regulatory oversight and scrutiny of healthtech companies has emerged as a priority for the U.S. federal government. Facing triple investigations by the Federal Trade Commission (FTC), Department of Justice (DOJ), and Drug Enforcement Administration (DEA), Cerebral has become a cautionary tale for healthtech companies looking to provide telemedicine services across the U.S.
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EU MDR Now Regulates Beauty Devices As Medical Devices
1/27/2023
The EU Regulation 745/2017 on medical devices (EU MDR) lists in Annex XVI several beauty devices that the EU Commission wants to regulate as medical devices, including colored contact lenses, cosmetic implants, cosmetic fillers, liposuction, light emitting equipment for skin resurfacing and other purposes, and brain stimulation devices.
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The FDA & EU IVDR Regulatory Frameworks For IVD SaMD
1/4/2023
Software that is qualified as an in vitro diagnostic medical device (known as SaMD IVD) is affected by the same requirements as other medical devices, which are governed by various FDA regulations and EU In Vitro Diagnostic (IVD) Regulation EU 2017/746.
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Does The FDA Or EU IVDR Consider IVD Software An IVD Medical Device?
12/16/2022
Software with a medical intended use can be embedded as part of a medical device, or it can also be considered a medical device by itself and regulated as Software as a Medical Device (SaMD). In vitro diagnostic devices are known as IVD SaMD. This article summarizes the regulatory requirements in the EU, governed by the In Vitro Diagnostics Regulation (IVDR), and the requirements in the U.S., governed by the FDA.
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4 Key Takeaways For Combination Products As We Move Into 2023
12/13/2022
The AFDO/RAPS Combination Product Summit brought together industry leaders along with representatives of the FDA's Office of Combination Products. Of the four key takeaways covered in this article, one of them is an update on upcoming FDA guidances on this segment of the industry.
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5 Steps To Eliminate Weak Links In Your Data Governance
12/2/2022
Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.
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FDA Vs. Congress: The Software Showdown
11/14/2022
September 2022 will be remembered as a seminal turning point in digital health in the U.S. With the FDA’s final guidance on Clinical Decision Support (CDS) software, the FDA disregards a Congressional directive when it enacted the 21st Century Cures Act in 2016.
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LATAM’s Regulatory Framework For Medtech Early Feasibility Studies
11/11/2022
Latin America is a compelling region to conduct medtech early feasibility studies due to its ethnically diverse population, its high rate of urbanization, and more. Here, the author spotlights Colombia, Brazil, and Mexico as the hotspots for medtech feasibility studies in Latin America.
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India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022
11/7/2022
To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?