FDA Warning Letter - Product Association with Search Engine Results - Problems Ahead?

Marcelo

Inactive Registered Visitor
#1
FDA Warning Letter Targets Product Association with Search Engine Results

"Typing the key word 'cancer' or 'diabetes' into MDR's product search field located on its website" brings up a number of products, FDA observed.

Because those products are associated with that particular search term, the company is thus "implying that its products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases," FDA said.
Hum...
 
Last edited:
Elsmar Forum Sponsor

Miner

Forum Moderator
Leader
Admin
#2
Re: Interesting problem - Warning Letter -Product Association with Search Engine Resu

The link is not working for me.
 

Marcelo

Inactive Registered Visitor
#7
Re: FDA Warning Letter - Product Association with Search Engine Results - Problems Ah

And this after the FDA decided not to pursue action for sales folks pitching off-label claims: http://www.fdalawblog.net/fda_law_bl...promotion.html
But this is not the same as the OP, right?

This one is related to prosecution something that is perceived as rightful, truthful discussion. The case in the OP is misleading.
 
G

Gert Sorensen

#8
Re: FDA Warning Letter - Product Association with Search Engine Results - Problems Ah

Well, it looks as though FDA is stepping up to the plate on this subject (websites, website information, SEO). They are not only targeting the manufacturers website content, they are now also targeting the use of SEO techniques :)

This is going to be fun to observe. Having seen quite a few warning letters that address the issue of websites and their contents, related to companies both in the US and abroad, I would not be surprised to see that FDA would be pursuing the possibility of blocking some websites (especially websites located abroad) from being accessed in the US, as part of their regulatory tool-kit.

Generally I think that the industry is not paying nearly enough attention to the violation of law that they may (perhaps inadvertently) commit in their use websites, and as a consequence they do not consider the legal implications. Or perhaps "they are just feeling lucky"? :)

On an off note: I wonder whether these issues will soon be addressed by regulators outside the US? Perhaps an upcoming subject for IMDRF?
 
M

MIREGMGR

#9
Re: FDA Warning Letter - Product Association with Search Engine Results - Problems Ah

Good for FDA...they're trying hard to do their job conscientiously even as communications technology becomes much more complex.
 

John Broomfield

Leader
Super Moderator
#10
Re: FDA Warning Letter - Product Association with Search Engine Results - Problems Ah

"Maintaining the Accuracy of Websites" was always a key process in any organizational management system.

I now see this process must be extended to include the accuracy of search results.

Thanks,

John
 
Thread starter Similar threads Forum Replies Date
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
P Warning Letter 1999 - Where does the FDA make older warning letters available? US Food and Drug Administration (FDA) 4
H Most Poorly Written FDA Warning Letter Ever? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
J FDA 483 Warning Letter for use of Calipers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
T FDA Form 483 Warning Letter - What next? US Food and Drug Administration (FDA) 7
S FDA Warning Letter Remediation - Enforcement Resolution & Remediation Process US Food and Drug Administration (FDA) 3
S FDA Warning Letter on Medical Device Reporting Interpretation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
AnaMariaVR2 St. Jude Medical does the unthinkable: Warns of FDA warning letter before FDA issues US Food and Drug Administration (FDA) 5
AnaMariaVR2 Warning Letter to Fercy Personal Care Products - company kicked out FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
A FDA 483 Warning Letter Response Time Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
AnaMariaVR2 FDA writes up Warning Letter to British Homeopathic Drugmaker US Food and Drug Administration (FDA) 0
Y Siemens Healthcare - FDA Warning Letter Analysis 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A FDA Audit Documentation - Recently released FDA Warning Letter Qualification and Validation (including 21 CFR Part 11) 12
AnaMariaVR2 Anulex sees layoffs after FDA warning letter 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A How long does it take US FDA to issue a Warning Letter Close Out Letter Other US Medical Device Regulations 2
E How to Respond to a US FDA untitled letter - Form 483 or Warning Letter Other US Medical Device Regulations 2
C The warning letter of ONBO - Why FDA require identification of 510(k) ownership? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
AnaMariaVR2 Warning ? Don?t Confuse ?Made In USA? And ?Inspected By FDA? With Patriotism US Food and Drug Administration (FDA) 3
AnaMariaVR2 Gilead plant joins the FDA's "warning club" US Food and Drug Administration (FDA) 0
K Where you can read other companys' 483 FDA Warning Letters 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
AnaMariaVR2 FDA Global Clampdown: 8 Warning Letters - Failing to Register Plants US Food and Drug Administration (FDA) 0
AnaMariaVR2 FDA issued Warning Letters to Beckman Coulter - 2011 US Food and Drug Administration (FDA) 1
Ajit Basrur FDA issues Warning Letters for misleading advertising of Lap-Band US Food and Drug Administration (FDA) 3
AnaMariaVR2 The Top 12 FDA 2011 Warning Letters Report US Food and Drug Administration (FDA) 7
AnaMariaVR2 FDA has issued three Warning Letters... US Food and Drug Administration (FDA) 13
F Breakdown and Analysis of FDA Warning Letters US Food and Drug Administration (FDA) 11
Ajit Basrur FDA Expands Warning on Eating Raw Oysters US Food and Drug Administration (FDA) 1
Ajit Basrur FDA warning on canned French Cut Green Beans US Food and Drug Administration (FDA) 4
E The FDA regulations (21 CFR 312.3): Is it allowable that IND sponsor involves more than one individual or organization? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
P Looking for Korean FDA Drug Master File requirements for packaging systems. Other Medical Device and Orthopedic Related Topics 1
M IEC 62366 Hazard-related Use Scenario vs FDA Critical Task EU Medical Device Regulations 3
N Free sale and FDA US Food and Drug Administration (FDA) 1
N FDA class 1 US Food and Drug Administration (FDA) 6
G UDI in EU vs FDA EU Medical Device Regulations 1
S Initial Audit FDA US Medical Device Regulations 3
T FDA PMA review process - advisory panel timing? Other Medical Device and Orthopedic Related Topics 0
E FDA & Internal Audits US Medical Device Regulations 3
N Importing into US without 510K/FDA Clearance US Medical Device Regulations 1
N FDA class 2 Device QS Requirements US Food and Drug Administration (FDA) 2
T FDA labeling requirements US Food and Drug Administration (FDA) 2
S FDA Contract Manufacturer and Applicant US Food and Drug Administration (FDA) 0
R IVD Software FDA/CLIA doubts Medical Device and FDA Regulations and Standards News 1
R IVD software FDA and CLIA US Food and Drug Administration (FDA) 2
T FDA level of concern vs IEC 62304 safety classification - 510(k) exempt device Other US Medical Device Regulations 13
K Change in address on ERLM US FDA: Implications to import US Medical Device Regulations 0
V FDA 510K - Pre Submission Query US Food and Drug Administration (FDA) 6
M Document Control ISO and FDA ISO 13485:2016 - Medical Device Quality Management Systems 7
C FDA 510k documentation requirements US Food and Drug Administration (FDA) 1
T Link GMDN code and FDA product code US Medical Device Regulations 5
cgaro62 Does FDA apply to a non-medical 13485 certified custom manufacturing company? ISO 13485:2016 - Medical Device Quality Management Systems 11

Similar threads

Top Bottom