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New From FDA:  Website Warning Letters

FDA has issued several warning letters (sample available by clicking here) charging medical device companies with labeling violations under 21 CFR 807 for web sites specifying more information than was included in cleared section 510(k) premarket notification or approved PMA (Premarket Approval applications).  How did FDA become aware of the websites?  At a recent industry meeting,  FDA announced that it has device reviewers routinely browsing company websites.   In one specific case, FDA charged:

"Both your website at http://www.axon.com and pages flom an ad submitted to the FDA (basically  identical to your website heading "GS 3000 Flyer") state that the Guideline System 3000 was developed for use in stereotactic functional neurosurge~/intraoperative microelectrode guidance during pallidotomy, thalamotomy, and the implantation of deep brain stimulators (DBS) for the treatment of Parkinson’s Disease and essential tremor...and...additionally, according to the ad,   the Guideline System 3000 claims to be 'FDA Approved... the first instrument of its kind to gain both US FDA approval...and ...cleared by the FDA for distribution in the USA.'   (This information was also noted on your website). The CD states under 'Warnings!' that 'the Guideline System 3000, manufactured by Axon Instruments, is the only equipment currently available that is FDA approved.'   21 CFR 807.97 specifically provides that any representation that creates an impression of official approval because of complying with the premarket notification regulations is misleading and constitutes misbranding. "

FDA has consistently advised that it considers advertising concerning device claims available in the public domain (magazines, published articles, press releases, etc.) to be regulated under 21 CFR 807.97.  Recently, FDA has said that manufacturers providing such device information on company websites will be regulated as such as well.   Further, FDA has said it believes it has enforcement authority over those websites "if physically located in the United States."  Is it likely that FDA is going to find your website and compare the information to that which was part of your device clearance or approval?  Well, The CRO Group clients have found this depends on recent device submissions or a competitor's "anonymous" tip, such as occurred in the specific case above.

Medical device company regulatory professionals may not even be aware that their company has a website, let alone whether its content would be considered in compliance if viewed by a FDA investigator.  Some medical device companies allow users to enter complaints about products, allowing FDA to review websites under 21 CFR 820 and 803 requirements (Quality System Customer Complaint and MDR reporting).

The CRO Group has two website programs for medical device manufacturers:

• A low cost web site compliance package including initial determination of applicable USA and EU regulations, assessment of compliance with those regulations, and corrective action plan for noncompliances.  Corrective action plans may include procedures for the IT department which is usually responsible for website maintenance.
• A small company web site creation package suitable for the small or startup company which includes: 
  • Corporate presence: company descriptions, product advertising & promotion (complies with 21 CFR 807)
  • Clinical trial information as applicable (complies with 21 CFR 812)
  • Customer complaint communications (complies with 21 CFR 820 and 803)
  • EU Targeted "Marketing Enhancement" (designed for capturing additional CE marking sales)

To obtain a quotation for either of these services, click here.

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