Lisa Dwyer on Federal Food Drug and Cosmetic Act (FFDCA)

FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more

4/7/2025 / Appeals , Civil Monetary Penalty , CLIA , Clinical Laboratories , Criminal Penalties , Department of Health and Human Services (HHS) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Judicial Authority , Laboratory Developed Tests , Medical Devices , Regulatory Agencies , Regulatory Authority , Statutory Interpretation

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

1/13/2025 / Artificial Intelligence , Cybersecurity , Data Management , Data Protection , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Life Sciences , Machine Learning , Medical Devices , Popular , Regulatory Requirements , Risk Assessment , Software

FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities

On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics (Draft Accelerated Approval...more

1/7/2025 / Applications , Clinical Trials , Consolidated Appropriations Act (CAA) , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA)

Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance

On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more

8/26/2024 / 510(k) RTA , Applications , Artificial Intelligence , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Impact Assessments , Machine Learning , Medical Devices , Modification , Pre-Market Notification , Software

DEA's Proposed Rule to Reschedule Marijuana Could Reduce Obstacles to Medical Research but Public Input Is Needed to Fill in...

On May 16, 2024, the U.S. Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to reclassify marijuana from Schedule I to Schedule III under the federal Controlled Substances Act (“CSA”) and...more

6/25/2024 / Cannabis-Related Businesses (CRBs) , Controlled Substances Act , DEA , Department of Health and Human Services (HHS) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Law Enforcement , Marijuana , Motion To Reschedule , Notice of Proposed Rulemaking (NOPR) , Proposed Rules , Research Funding , Schedule I Drugs , Tax Deductions

LDT Final Rule: Shifting the LDT Battlefield

On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more

5/1/2024 / Compliance , Enforcement , False Statements , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Labeling , Medical Devices , Misleading Statements , Premarket Approval Applications , Proposed Rules , Public Health

FDA Finalizes Premarket Cybersecurity Guidance for Medical Devices

On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more

10/11/2023 / Artificial Intelligence , Cybersecurity , Federal Food Drug and Cosmetic Act (FFDCA) , Final Guidance , Food and Drug Administration (FDA) , Homeland Security Cybersecurity & Infrastructure Security Agency (CISA) , Machine Learning , Medical Devices , NTIA , Popular , Premarket Approval Applications , Risk Management , Software , Source Code

FDA's Latest Salvo in the LDT Wars

On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more

10/3/2023 / CLIA , Draft Guidance , Emergency Use Authorization (EUA) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Jurisdiction , Laboratory Developed Tests , Litigation Strategies , Medical Devices , Proposed Rules , Public Comment , Reporting Requirements , Warning Letters

FDA Publishes Draft AI/ML-Enabled Medical Device Guidance. Is it Everything We Hoped?

First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” the idea of a defined set of...more

4/7/2023 / Algorithms , Artificial Intelligence , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , Policies and Procedures , Transparency

Not Quite the Titanic: The Food and Drug Omnibus Reform Act Rescues Some FDA Policy Initiatives

The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more

Nearly a Century in the Making: Congress Modernizes FDA’s Regulation of Cosmetics

The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more

1/10/2023 / Animal Testing , Asbestos , Cosmetics , Distributors , Draft Guidance , EU , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Act , Food and Drug Administration (FDA) , Labeling , Manufacturers , New Regulations , PFAS , Product Recalls , Product Safety Labels , Suspensions

FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance

On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more

12/20/2022 / Citations , Draft Guidance , FDARA , FDASIA , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Inspections , Manufacturers , Medical Devices , OSHA , Pharmaceutical Industry , Prescription Drugs

FDA’s Final Clinical Decision Support Guidance: The Good News and the (Really) Bad News

On September 28, 2022, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited final guidance, “Clinical Decision Support Software” (the “Final CDS Guidance”). The Final CDS Guidance supersedes...more

10/13/2022 / 21st Century Cures Act , Algorithms , CDS , Federal Food Drug and Cosmetic Act (FFDCA) , Final Guidance , Food and Drug Administration (FDA) , Health Care Providers , International Medical Device Regulators Forum (IMDRF) , Proprietary Information , Software

Act II: The Senate Unveils Its Draft

On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more

6/2/2022 / Animal Testing , BsUFA , Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , DSHEA , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , GDUFA , HELP , Manufacturers , Medical Device User Fee Program (MDUFA IV) , PDUFA , PFAS , Prescription Drugs , Public Health , Public Health Service Act , Purple Book , REMS , Title III

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

FDA Rejects Bids To Market CBD-Based Dietary Supplements

On July 23, 2021, the U.S. Food and Drug Administration (“FDA” or “Agency”) rejected two New Dietary Ingredient (“NDI”) notifications to market full-spectrum cannabidiol (“CBD”) as part of dietary supplements. This move...more

8/30/2021 / Cannabidiol (CBD) oil , Dietary Supplements , Farm Bill , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Product Labels

FDA Finalizes “Intended Use” Regulations

On August 2, 2021, the U.S. Food & Drug Administration (“FDA” or “the Agency”) published a final rule amending its medical product “intended use” regulations in an effort to provide direction and clarity to regulated industry...more

8/9/2021 / Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Intended Use , Off-Label Use , Pharmaceutical Industry , Proposed Rules

Genus Medical Technologies LLC v. FDA: D.C. Circuit Holds FDA Cannot Regulate Devices as Drugs

FDA regulation of biomedical products can be like a very complex game theory decision tree. Choices made at each intersection impact the ultimate regulatory framework under which any given product is developed, seeks...more

5/5/2021 / En Banc Review , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Petition for Writ of Certiorari , Pharmaceutical Industry , Prescription Drugs , SCOTUS

USDA Issues Final Rule to Establish Domestic Hemp Production Program and Approve State and Tribal Oversight Plans

Effective March 22, 2021, USDA’s Final Rule Sets Forth Regime for Producing Hemp Products in the United States, Superseding Interim Rule - On January 9, 2021, the U.S. Department of Agriculture (USDA) issued a final rule...more

2/3/2021 / Biden Administration , Cannabidiol (CBD) oil , Corrective Actions , DEA , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Hemp , Hemp Cultivation , Notice of Violation , USDA

FDA Proposes New Rule Modifying its “Intended Use” Regulations

Yesterday, FDA published a proposed rule amending its medical product “intended use” regulations in an effort to “provide direction and clarity to regulated industry and other stakeholders.” If finalized, the rule would amend...more

9/25/2020 / Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Intended Use , Pharmaceutical Industry , Proposed Rules

Trump Administration Continues to Promote Drug Importation as a Way to Lower the Cost of Prescription Drugs

On July 24, 2020, President Trump issued a series of Executive Orders to address prescription drug costs, one of which specifically focuses on facilitating drug importation, a longstanding goal of the Trump Administration....more

7/31/2020 / Department of Health and Human Services (HHS) , Executive Orders , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medicare Prescription Drug Improvement and Modernization Act (MMA) , Notice of Proposed Rulemaking (NOPR) , Prescription Drugs , Public Safety , State Implementation Plans (SIPs) , Trump Administration , Waivers

FDA Releases Progress Report Regarding Enforcement Discretion Policy on Hemp-Derived Cannabidiol (CBD)

Last week, FDA submitted a report to Congress detailing the Agency’s progress on developing an enforcement discretion policy (i.e., a policy of not taking enforcement action) on hemp-derived cannabidiol (CBD). At the same...more

3/10/2020 / Cannabidiol (CBD) oil , Cannabis Products , Controlled Substances Act , Decriminalization of Marijuana , Enforcement Actions , Farm Bill , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Health and Safety , Hemp , Marijuana , Marijuana Cultivation , Marijuana Related Businesses , Public Hearing , Regulatory Oversight , Risk Management

4/8/2019 / Agricultural Sector , Cannabidiol (CBD) oil , Enforcement , Farm Bill , Federal Food Drug and Cosmetic Act (FFDCA) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Marijuana , Marijuana Related Businesses , Public Comment , Public Health , Public Meetings , Public Notice , Regulatory Agenda , Regulatory Authority , Warning Letters

Lisa Dwyer

King & Spalding

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