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Aug 7, 2024 | 
jdsupra.com | Jason Conaty |Ashley Grey |Randy Prebula
“Combination products” are comprised of two or more different types of products (i.e., a combination of a drug, device, and/or biological product).
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Aug 7, 2024 | 
lexology.com | Randy Prebula |Jason Conaty |Eva Schifini |Ashley Grey
The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance to align it with current user fee program expectations.
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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The U.S. Food and Drug Administration (FDA) issued the revised draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs,” which clarifies how firms can address misinformation about their approved medical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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Jun 6, 2024 | 
jdsupra.com | Suzanne Friedman |Wil Henderson |Randy Prebula
Last month, FDA finalized its landmark proposed rule that would amend the definition of “in vitro diagnostic (IVD) products” in 21 CFR 809.3, effective May 6, 2024, to make explicit that IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA), “including when the manufacturer of the IVD is a laboratory.” In summarizing the final rule online here at the time, we predicted that litigation against the rule was likely.
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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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Mar 12, 2024 | 
jdsupra.com | William Ferreira |Heidi Forster Gertner |Randy Prebula
The draft guidance provides recommendations on how to present key information at the start of an informed consent process, which should include topics that are generally important for clinical trial participants to understand, including: the purpose of the research, the possible risks and benefits of the study, and the study’s length and procedures.
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Mar 11, 2024 | 
lexology.com | Heidi Forster Gertner |Bill Ferreira |Randy Prebula |Yetunde Fadahunsi |Will Tenbarge
As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) published new draft guidance on how to present key information at the beginning of an informed consent document.
