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Jan 22, 2025 | 
jdsupra.com | Suzanne Friedman |Sally Gu |Komal Karnik Nigam
[co-author: Gabrielle Simeck]The U.S. Food and Drug Administration (FDA) has published final guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU Guidance), which describes permitted dissemination of scientific information on unapproved uses (SIUU) of approved/cleared medical products by firms to healthcare providers (HCPs).
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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On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which consolidates the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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Aug 30, 2024 | 
jdsupra.com | Suzanne Friedman |Kelliann H. Payne
A predetermined change control plan (PCCP) is documentation describing what modifications will be made to a device after its initial premarket authorization without requiring a new marketing submission to FDA, and how these modifications will be assessed. Modifications to medical devices that could affect the safety or effectiveness of the device require premarket authorization from FDA.
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Aug 30, 2024 | 
lexology.com | Kelliann H. Payne |Suzanne Friedman
The U.S. Food and Drug Administration (FDA) has published new draft guidance on “Predetermined Change Control Plans for Medical Devices,” which describes the process by which device sponsors may seek FDA approval for modifications in advance by submitting a PCCP document, which would describe the anticipated changes and how they will be tested and implemented.
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Jul 18, 2024 | 
jdsupra.com | Suzanne Friedman |Wil Henderson |Komal Karnik Nigam
Below, we analyze the changes to the updated enforcement policy and provide key takeaways for entities responsible for communication regarding approved/cleared medical products. FDA’s revised draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs” clarifies a safe harbor described in the 2014 draft guidance for companies voluntarily addressing misinformation on the internet and social media.
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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 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 7, 2024 | 
jdsupra.com | Erkang Ai |Brooke Bumpers |Suzanne Friedman
FDA has finalized its landmark proposed rule that will amend the definition of “in vitro diagnostic (IVD) products” in 21 CFR § 809.3 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.” We previously analyzed the October 2023 proposed rule (Notice of Proposed Rulemaking (NPRM)) online here, providing background in that article on FDA’s decades-long history of exercising enforcement...
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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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Jun 27, 2023 | 
jdsupra.com | Suzanne Friedman |Lina R. Kontos |Kelliann H. Payne
As discussed in the final guidance, FDA anticipates that the agency and industry will need up to 60 days after the publication of this guidance to operationalize the recommendations discussed; however, CDRH intends to review information submitted according to the new guidance at any time.
