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2 months ago | 
jdsupra.com | Penny Powell |Matthias Schweiger |Jodi Scott
In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, there is no comprehensive federal AI legislation, but at least 45 states have introduced bills that would regulate AI, with 31 having enacted such legislation.
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Jan 15, 2025 | 
jdsupra.com | Suzanne Friedman |Kelliann H. Payne |Jodi Scott
On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which consolidates the recommendations that FDA has been providing over the years on the content needed in a marketing application pertaining to a device with AI-enabled software functions in order to facilitate FDA’s determination as to the safety and effectiveness of the device...
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Jan 7, 2025 | 
jdsupra.com | Penny Powell |Matthias Schweiger |Jodi Scott
Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI technologies rapidly evolve, global regulators face the complex task of regulating AI to ensure patient safety, while still fostering innovation.
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Jul 17, 2024 | 
lexology.com | Suzanne Friedman |Komal Karnik Nigam |Jodi Scott |Wil Henderson |Randy Prebula
The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how firms can address misinformation about their approved medical products posted by independent third parties.
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Jun 27, 2024 | 
jdsupra.com | Randy Prebula |Jodi Scott |Blake Wilson
The U.S. Food and Drug Administration (FDA) announced yesterday a “Small Entity Compliance Guide” (SECG) for Laboratory Developed Tests (LDTs), aiming to assist small entities in complying with FDA’s LDT final rule, which would regulate in vitro diagnostic (IVD) products and LDTs as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA), should the final rule take effect on July 5. We have summarized the SECG below, including FDA’s enforcement timeline for the LDT final rule.
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May 30, 2024 | 
jdsupra.com | Michael Heyl |Randy Prebula |Jodi Scott
May 30, 2024 Michael Heyl, Randy Prebula, Jodi Scott Hogan Lovells + Follow x Following x Following - Unfollow Contact To embed, copy and paste the code into your website or blog: The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Remanufacturing of Medical Devices,” clarifying the point when manipulation or repair of a medical device becomes “remanufacturing” as opposed to “servicing.” Although the final version of the guidance mostly resembles the draft guidance, FDA...
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May 29, 2024 | 
lexology.com | Jodi Scott |Michael Heyl |Randy Prebula
The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Remanufacturing of Medical Devices,” clarifying the point when manipulation or repair of a medical device becomes “remanufacturing” as opposed to “servicing.” Although the final version of the guidance mostly resembles the draft guidance, FDA adds detailed examples and analyses of the regulatory requirements and considerations for “remanufacturers,” emphasizing their obligations to comply with agency rules relating to...
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May 6, 2024 | 
lexology.com | Jodi Scott |Lowell Zeta |Blake Wilson |Randy Prebula |Brooke Bumpers |Suzanne Friedman | +2 more
The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below we summarize the most notable changes between the proposed rule and Final Rule, including the grandfathering provision and inclusion of more carve-outs for categories of tests that will continue to receive enforcement discretion.
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Feb 26, 2024 | 
lexology.com | Randy Prebula |Jodi Scott |Kristin Zielinski Duggan
On Tuesday, the U.S. Food and Drug Administration (FDA) issued a letter warning medical device manufacturers and sponsors of device studies to carefully evaluate the third parties that they engage to conduct performance testing, and to independently verify all testing results to the extent possible before submitting data to FDA.
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Feb 6, 2024 | 
lexology.com | Michael Heyl |Lina R. Kontos |Jodi Scott |Wil Henderson
The U.S. Food and Drug Administration (FDA) published its long-awaited final rule to amend the Quality System Regulation’s (QSR’s) current good manufacturing practice (CGMP) requirements for medical devices.
