Tag Archives: warning letter

FDA Advertising and Promotion Enforcement Activities in March 2014

The Office of Compliance (OC) in the FDA’s Center for Devices and Radiological Health issued a warning letter to NeoMedix Corporation regarding the Trabectome High Frequency Generator/LP (Trabectome) on February 26, 2014. The warning letter included allegations that Neomedix’s website made claims about Trabectome that represented a “major change or modification” of the device’s intended … 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

New Study Shows Increased Enforcement Action

A new study released this week by medical device firm Emergo Group shows a steady increase in FDA inspections of medical device manufacturers since 2009.  The study showed that FDA quality system inspections between 2005 and 2009 numbered around 1500 inspections a year.  However, between 2010 and 2012, FDA averaged approximately 2000 inspections a year—about … 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

FDA Requests Comments Regarding Amended “Custom Devices” Exemption

On November 19, 2012, FDA issued a Federal Register notice seeking public comments on amendments to the custom device exemption that were enacted as part of the Food and Drug Administration Safety and Innovation Act (FDASIA).  FDA also announced it intends to issue a draft guidance relating to custom devices in 2013, as the Agency’s … 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