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U.S. Government Shutdown 2025 (Week 1):  Early Insights into FDA Operations

By Delia Deschaine, John Wyand and Xiaomei Cai on Posted in Events, FDA
The 2025 U.S. government shutdown kicked in effective at 12:01am, October 1, 2025, and as of this posting, has been in place for over a week.  The shutdown will continue indefinitely until Congress unifies and resolves the budget impasse. The U.S. Food and Drug Administration (“FDA”), tasked with protecting public health by ensuring the safety, … Continue Reading

Food and Drug Administration (FDA) Issues Draft Guidance on Transfer of 510(k)s

By Squire Patton Boggs on Posted in FDA, Medical Device, Technology
On June 5, 2025, the FDA issued draft guidance addressing frequently asked questions regarding the transfer or sale of a 510(k) clearance from one 510(k) holder to another. As transfer of 510(k)s is a common issue during transactions involving medical devices, this guidance, if finalized as written, will provide helpful insight regarding the FDA’s position … Continue Reading

District Court Strikes Down FDA’s LDT Rule, Opens the Door for Challenges to FDA’s Regulation of Other “Services” as Medical Devices

By Keith Bradley, Delia Deschaine and Samuel Ballingrud on Posted in FDA, Regulations
On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s 2024 Rule regulating as “devices” under the Food, Drug, and Cosmetic Act (“FDCA”), certain laboratory-developed test (“LDTs”) used to diagnose, monitor, or determine treatment for diseases and conditions. The decision, American Clinical Laboratory Assoc. v. … Continue Reading

FDA Delays Enforcement of MOCRA Deadlines for Facility Registration and Product Listing to July 1, 2024

By John Wyand, Jennifer Tharp, Jennifer Satterfield and Madeline Mischler on Posted in FDA, Life Sciences
Background President Biden signed into law the “Consolidated Appropriations Act, 2023” on December 29, 2022. The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”), which increased the authority of the United States Food and Drug Administration (FDA) to regulate cosmetics products and provide enhanced cosmetics protections for consumers. For insight, please see … Continue Reading

Revamping Cosmetics Safety and Regulation: Updates from FDA on Regulatory Changes under MOCRA.

By John Wyand, Jennifer Tharp, Jennifer Satterfield and Madeline Mischler on Posted in FDA, Life Sciences
On December 29, 2022, President Biden signed into law the “Consolidated Appropriations Act, 2023.” The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”), which increased the authority of the United States Food and Drug Administration (FDA) to regulate cosmetics products and provide enhanced cosmetics protections for consumers. For insight, please see our … Continue Reading

Roadmap to the Phased Transition Process for Medical Devices after Covid-19 Public Health Emergency

By John Wyand, Charli Davis, Jennifer Tharp and Nicole Bothwell on Posted in COVID-19, FDA, Life Sciences, Medical Device
On March 27, 2023, the U.S. Food &Drug Administration (FDA) released two final guidance documents to assist with the transition of medical devices that were legally distributed: (1) subject to certain enforcement policies issued during the COVID-19 public health emergency (PHE) or (2) Emergency Use Authorizations (EUAs). Manufacturers, distributors, and industry stakeholders that have products … Continue Reading

Revamping of Cosmetics Regulation and Safety

By Squire Patton Boggs on Posted in FDA, Regulations
President Biden signed into law the “Consolidated Appropriations Act, 2023” on December 29, 2022 (the enactment date). The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) which increases the authority of the United States Food and Drug Administration (“FDA”) to regulate cosmetics and provide enhanced protections for consumers. The new law includes … Continue Reading

FDA Issued Enforcement Discretion Measures for Infant Formula

By Jennifer Tharp on Posted in FDA, Supply Chain
In recognition of the infant formula crisis facing the United States supply chain, the Food and Drug Administration (“FDA”) issued guidance on May 16, 2022 providing for enforcement discretion with respect to certain requirements for infant formulas that may not comply with certain statutory and regulatory requirements. The guidance remains in effect until November 14, … Continue Reading

FDA Revokes EUAs for Certain Non-NIOSH Respirators – A Sign of More to Come?

By Jennifer Tharp on Posted in COVID-19, FDA
More than a year after issuing Emergency Use Authorizations (“EUAs”) for filtering facepiece respirators (“FFRs”), surgical masks, and related personal protective equipment (“PPE”), the Food and Drug Administration (“FDA”) is walking back these measures. On June 30, 2021 the FDA announced the revocation of the EUAs for all imported, disposable FFRs not approved by the … Continue Reading

A Respite for Potential Liability for Face Masks

By Nicole Bothwell and Jennifer Tharp on Posted in COVID-19, FDA
Since April 8, 2020, seven states (in order of adoption: New Jersey, Rhode Island, New York, Maryland, Hawaii, Connecticut and Pennsylvania) have issued executive orders (“EOs”) requiring the wearing of face masks in various situations, ranging from being in a public place where close contact may be unavoidable, riding public transportation, working or shopping at … Continue Reading

A Broad Emergency Use Authorization for Face Masks

By Nicole Bothwell and Jennifer Tharp on Posted in COVID-19, FDA
On April 18, 2020, FDA issued a new Emergency Use Authorization (“EUA”) relating to non-surgical face masks with broad coverage and implications for recent industry participants manufacturing face masks. The EUA applies to the broad class of non-surgical face masks used to cover a person’s nose and mouth. Please see our prior blog post for … Continue Reading

Shortages of PPE Drive FDA Guidance and Emergency Use Authorizations

By Jennifer Tharp and Nicole Bothwell on Posted in COVID-19, FDA
Background On January 31, 2020, the Secretary of the Department of Health and Human Services (“HHS”), Alex M. Azar II, declared a public health emergency due to a virus named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), or coronavirus, which causes novel coronavirus disease 2019 (“COVID-19”).  In the weeks following the declaration of the public … Continue Reading

Government Shutdown – Does It Affect My Research Grant or Contract? It May

By Squire Patton Boggs and David LesStrang on Posted in FDA, NIH
A lapse in federal funding, or a government shutdown, occurs when Congress and the President fail to agree to a new appropriations bill for oneor more of the federal government agencies. The most recent partial government shutdown, ending in January 2019, affected about 25% of government agencies (in dollar terms). The Department of Homeland Security … Continue Reading

Digital Health Update: Recent FDA Cyber Initiatives

By Jennifer Tharp on Posted in Cybersecurity, Data Protection, Department of Health and Human Services, Digital Health, FDA, Life Sciences, Medical Device, Policy, Regulatory Compliance, Technology
The Food and Drug Administration (“FDA”) has greatly increased its activity around cybersecurity initiatives and medical devices. As we approach the end of the year, this is a great opportunity to review recent developments. FDA Medical Device Cybersecurity Guidance On October 18, 2018, the FDA published draft guidance, “Content of Premarket Submissions for Management of … Continue Reading

FCC COMMENCES INQUIRY ON ESTABLISHING $100-MILLION TELEHEALTH PILOT PROGRAM

By John Wyand and Paul Besozzi on Posted in Digital Health, FDA, Policy, Telehealth
FCC COMMENCES INQUIRY ON ESTABLISHING $100M TELEHEALTH PILOT PROGRAM On August 2, 2018, The Federal Communications Commission has unanimously approved a Notice of Inquiry (“NOI”) to establish a $100-million  telehealth pilot program. FCC seeks to identify how the agency can “help advance and support the movement in telehealth towards connected care everywhere and improve access … Continue Reading

Squire Patton Boggs Attorneys Publish Practical Law Practice Note on State Legalized Marijuana Businesses and Access to the Bankruptcy Code

By John Wyand on Posted in Bankruptcy, Compliance, DEA, DOJ, Drug, FDA, Life Sciences, Pharmaceutical, Policy
The June 13, 2018 publication of Practical Law features a Practice Note co-written by Squire Patton Boggs attorneys Mark A. Salzberg, Elliot M. Smith, John E. Wyand and Sarah H. Stec titled “State Legalized Marijuana Businesses and Access to the Bankruptcy Code”. The Practice Note discusses the federal statutory scheme governing marijuana, its tension with … Continue Reading

Right to Try Investigational Drugs Signed Into Law

By John Wyand on Posted in Department of Health and Human Services, FDA, Insurance, Life Sciences, Pharmaceutical, Policy
Right to Try Investigational Drugs Signed Into Law On May 30, 2018, S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Pub. L. No. 115-176, “Right to Try Act”) was signed into law. The Right to Try Act amends the Federal Food, Drug, and Cosmetic Act … Continue Reading

FDA Approves Marketing of Clinical Decision Support Software for Stroke Triage in Midst of Renewed Focus on Digital Health Applications

By Jennifer Tharp on Posted in FDA, Technology
The U.S. Food and Drug Administration (“FDA”) recently approved the Viz.Ai Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify providers of a potential stroke in their patients. In an article published March 8, 2018 as a PG Alert Email from the American Health Lawyers … Continue Reading

FDA Issues Guidance on Clinical and Patient Decision Support Software

By Squire Patton Boggs and John Wyand on Posted in FDA, Life Sciences, Medical Device, Medical Device, Publications
On December 8, 2017, the Food and Drug Administration (FDA) published a notice of availability for the Clinical and Patient Decision Support Software – Clinical and Patient Decision Support Software – Draft Guidance for Industry and Food and Drug Administration Staff (“Draft Guidance”). The Draft Guidance provides clarity on the scope of FDA’s regulatory oversight … Continue Reading

Summary of FDA Statement on Laboratory Developed Tests Issued January 13, 2017

By Squire Patton Boggs on Posted in Compliance, FDA, Medical Device
On January 13, 2017, the Food and Drug Administration (FDA) issued a discussion paper on laboratory developed tests (LDT) synthesizing the regulatory dialogue that FDA and stakeholders have had since 2010 and outlining future regulatory possibilities for LDTs.  FDA and a majority of stakeholders support a complimentary approach to regulating LDTs that combines FDA’s experience … Continue Reading

FDA Issues Guidance for Classification Pathways for New Accessory Types

By John Wyand on Posted in Compliance, FDA, Medical Device, Medical Device, Publications
Accessories to medical devices play an integral role for their parent medical devices, supporting or adding to the parent device’s functionality.  Accessories historically took the classification of the parent device, except in cases where the Food and Drug Administration (“FDA”) classified the accessory in its own right.    The 21st Century Cures Act, passed into law … Continue Reading

FDA Working to Modernize Medical Device Reporting in Hospitals

By John Wyand on Posted in FDA, Hospitals, Regulatory Compliance
Recent medical device adverse events prompted FDA to take a fresh look at the ways it collects data related to medical device adverse events from hospitals.  FDA examined some high-profile adverse events, such as the spread of uterine cancer from the use of morcellators and the spread of infections by contaminated duoendoscopes, and found it … Continue Reading

BREAKING: Deal Reached on New EU Medical Device and IVD Regulations

By Squire Patton Boggs on Posted in EU, FDA, International, International Healthcare, Medical Device, Regulatory Compliance
On May 25, 2016, the European Union (“EU”) Council and Parliament politically agreed on the provisions that will go into the final version of the long-awaited EU medical device and in vitro diagnostic (“IVD”) regulations.  The agreement seeks to fill the regulatory gaps uncovered as technology evolved faster than the current regulatory regime, which had … Continue Reading

FDA Considers Regulating Refurbishers and Other Third Parties

By Squire Patton Boggs on Posted in FDA, International Healthcare, Legislation, Medical Device, Medical Device, Pharmaceutical, Quality and Performance Measures, Regulatory Compliance
The Food and Drug Administration (FDA) requested comments on March 4 regarding definitions and possible regulations governing medical device refurbishers, reprocessors, and other third parties. Medical device manufacturers have the duty, under 21 C.F.R. Part 820, to provide instructions to third parties that may service or install their products.  However, manufacturers may not be able … Continue Reading
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