On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, Inspection of Medical Device Manufacturers (CP 7382.850), to explain how the agency intends to conduct...more
2/4/2026
/ Compliance Management Systems ,
Cybersecurity ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Manufacturer Liability ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Quality Assurance Programs ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management
On December 17, the U.S. Food and Drug Administration (FDA) finalized its long-awaited guidance on the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” clarifying how FDA evaluates...more
FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed to prepare industry for the February 2, 2026 effective date of the Quality...more
Since Congress did not enact an FY 2026 appropriation or a funding extension, the federal government shut down on Wednesday, October 1, at 12:01 a.m. The U.S. Food and Drug Administration (FDA) won't fully shut down along...more
10/1/2025
/ Anti-Deficiency Act ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Oversight ,
Trump Administration ,
User Fees
In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
8/25/2025
/ Artificial Intelligence ,
Clinical Trials ,
Cybersecurity ,
Digital Health ,
Environmental Social & Governance (ESG) ,
Genetic Materials ,
Government Agencies ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Supply Chain ,
Trump Administration
FDA decided to rescind the LDT rule after declining to appeal a district court decision vacating it. The rule reflected FDA’s latest attempt to regulate LDTs under the same framework as IVDs, which FDA considers medical...more
The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records request authority and virtual...more
The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more
The U.S. Food and Drug Administration (FDA) announced new Q&A draft guidance on the “Transfer of a Premarket Notification (510(k)) Clearance,” which provides information on the most frequently asked questions regarding...more
Yesterday, the U.S. District Court for the Eastern District of Texas vacated the U.S. Food and Drug Administration’s 2024 rule that aimed to regulate laboratory-developed tests (LDTs) as medical devices, deciding it is...more
On February 28, 2025, the Department of Health and Human Services (“HHS” or “the Department”) issued a Policy Statement rescinding long-standing HHS guidance regarding the use of notice-and-comment rulemaking to adopt certain...more
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...more
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...more
The U.S. Supreme Court has issued its highly anticipated decision overturning the 40-year old doctrine established in Chevron v. Natural Resources Defense Council, which recognized judicial deference to administrative...more
7/15/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Statutory Interpretation
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...more
In the Eastern District of Texas U.S. federal court, the American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, have filed a lawsuit against the Food and Drug Administration (FDA), claiming the...more
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...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...more
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...more
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...more
The U.S. Food and Drug Administration (FDA) signaled that it intends to finalize its laboratory developed test (LDT) proposed rule by April 2024. The new rule (if finalized as drafted) is intended to clarify the agency’s...more
Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings and liquid wound washes containing antimicrobials, which would categorize...more
The U.S. Food and Drug Administration (FDA) has revised its guidance on non-invasive remote monitoring devices used to support at-home patient monitoring, replacing its March 2020 guidance that was limited in effect to the...more
The U.S. Food and Drug Administration (FDA) published new draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software” (PDS Guidance), which describes how FDA intends to apply its drug labeling...more
In a landmark proposed rule published Friday, the U.S. Food and Drug Administration (FDA) announced plans to make explicit that in vitro diagnostic products (IVDs), including in cases where the manufacturer of the IVD is a...more