Tag Archives: promotional claims

FDA Draft Guidance Addresses Medical Device Status of Microneedling Products

On September 15, 2017, FDA published a draft guidance document titled “Regulatory Considerations for Microneedling Devices” (Draft Guidance). The Draft Guidance describes when a microneedling product is a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) and discusses the regulatory pathway for microneedling devices. Interested parties have 60 days, … Continue Reading

Upcoming Webinar: “Advertising Drugs and Health Care Products via Social Media: FDA Regulation”

On Wednesday, May 7, Covington attorneys Stefanie Doebler and Saurabh Anand will be participating in a webinar that might be of interest to many of the readers of this blog.  The presentation, entitled “Advertising Drugs and Health Care Products via Social Media,” will provide attendees with an overview of a recent FDA draft guidance addressing … Continue Reading

CFDA Announces “Five Rectifications Campaign” Targeting Medical Devices

On March 13, 2014, the China Food and Drug Administration (CFDA) announced the Five Rectifications Campaign, a special five-month enforcement campaign targeting medical devices. The Campaign will focus on medical device registration, manufacturing, distribution, advertising, and use in healthcare institutions.  The campaign began on March 15, 2014 and will end on August 15, 2014.… Continue Reading

FDA Issues Untitled Letter Focused On Promotional Claims On Facebook

On March 12, FDA’s Office of Prescription Drug Promotion (OPDP) posted an untitled letter on its webpage alleging that Institut Biochimique SA’s (IBSA) Facebook page for the drug Tirosint® misbranded the drug.  Though the enforcement letter discusses a drug, the principles discussed in the letter are instructive for medical device promotion activities.  The untitled letter … Continue Reading

FDA Issues Draft Guidance on Postmarketing Requirements for Promotion on Social Media

On January 13, 2014, FDA issued a draft guidance document entitled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.”  This draft guidance addresses the procedural topic of submitting Forms FDA 2253 and 2301 when firms use social media such as blogs, microblogs, social networking sites, … Continue Reading

Summary of FDA Advertising and Promotion Enforcement Activities in June 2013

Covington & Burling LLP issues monthly e-alerts summarizing publicly-available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of drugs, medical devices, and biologics.  In June 2013, FDA’s Office of Prescription Drug Promotion (OPDP) posted one such letter.  Although the Center for Devices and Radiological Health (CDRH) posted no … Continue Reading

Summary of FDA Advertising and Promotion Enforcement Activities in April 2013

Covington & Burling LLP issues monthly e-alerts summarizing publicly-available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of drugs, medical devices, and biologics.  In April 2013, FDA’s Office of Prescription Drug Promotion (OPDP), Center for Devices and Radiological Health (CDRH), and Office of Compliance and Biologics Quality (OCBQ) … Continue Reading

FDA Issues Draft Guidance on Molecular Diagnostic Instruments with “Combined Functions” That Reflects Regulatory Creep

On April 9, 2013, FDA published a Federal Register notice announcing a new draft guidance on molecular diagnostic instruments with “combined functions” — i.e., combining functions subject to FDA approval or clearance as well as functions not subject to FDA approval or clearance (such as research use only (RUO)).  The draft guidance has significant implications … Continue Reading

FTC Releases New Guidance For Online Advertising Disclosures

Editor’s Note: This post originally appeared on our sister blogs, InsideTechMedia and Inside Privacy.   This FTC guidance will be of interest to device manufacturers, since the  FTC regulates advertising of non-restricted devices, and FDA is continuing to consider its regulatory policies for use of the internet and social media.  We note that FDA may … Continue Reading

Summary of 2012 FDA Promotional Enforcement Activity

In 2012, the Office of Compliance at CDRH issued 15 warning letters relating to the promotion of approved or cleared medical devices, a significant increase from both 2011 and 2010.  CDRH’s letters cited a variety of promotional materials, including Twitter posts and billboards, but websites were by far the most prominently featured promotional piece in … Continue Reading

Summary of Four Recent FDA Warning Letters on Device Advertising/Promotion Activities Now Available

In November, the Office of Compliance (OC) in FDA’s Center for Devices and Radiological Health (CDRH) posted on its website four warning letters relating to the advertising and promotion of medical devices: Warning letter to Quanta Systems, S.p.A. re: Quanta Q-Plus (Q-Plus Series) and Light Series Laser models (October 18, 2012) Warning letter to NeuroMed Devices, Inc. … Continue Reading

Device Companies Under Increased Government Scrutiny

Scrutiny of medical device companies by federal prosecutors is expected to increase in the coming years. As reported in a recent trade publication, Susan Winkler, a lawyer in the U.S. Attorney’s Office in the District of Massachusetts and former chief of that Office’s healthcare fraud unit, has stated that device companies have received less attention … Continue Reading

Fungal Meningitis Outbreak: FDA Targets Promotional Claims in a Public Health Crisis

Earlier this month, FDA’s Center for Devices and Radiological Health (“CDRH”) issued a warning letter to The Avalon Effect, Inc. (“Avalon”), regarding the company’s Quantum Series Personal Wellness Pack (“Wellness Pack”).  Even more notable than the November 5, 2012 warning letter is what accompanied it: a press release announcing FDA’s issuance of the warning letter … Continue Reading
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