Using the phrase "Approved by FDA" in Marketing and Advertising Material

Le Chiffre

Quite Involved in Discussions
#1
This is obviously a no-no. I'm looking at submitting a 510(k) application soon and have got used to seeing the term "FDA Approval" in marketing and advertising material.
I've read the thread here on Reference to FDA on label or labelling and also the FDA's guidance document on labeling (470.pdf) and CFR 807.97.

So what's the alternative to "FDA Approved" for use in advertising and marketing?
"Cleared for sale by the FDA"
"Cleared for sale in the U.S."
"Legally marketable"
"FDA doesn't object to me selling this" :tg:
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
"Cleared for sale by the FDA"
On a professional-only product, you probably could get away with that. On the other hand, if it's at a major show and something has caused them to initiate a crackdown on implied-endorsement claims, they might whack you.

On a consumer product, that definitely wouldn't fly.

"Cleared for sale in the U.S."
"Legally marketable"
Those both work, assuming they're used in regard to non-controversial products and are technically true. Or you can just state "FDA 510(K) 123456".
 

Michael Malis

Quite Involved in Discussions
#3
On a professional-only product, you probably could get away with that. On the other hand, if it's at a major show and something has caused them to initiate a crackdown on implied-endorsement claims, they might whack you.

On a consumer product, that definitely wouldn't fly.



Those both work, assuming they're used in regard to non-controversial products and are technically true. Or you can just state "FDA 510(K) 123456".
"Cleared for sale in US"

FDA does not "approve" anything...
 

Ajit Basrur

Staff member
Admin
#4
"FDA Approved" is a purely Sales / marketing gimmick. Pl do not use the terms.

My recommendation is not to use any of such terms. Is it really required ?
 
M

MIREGMGR

#5
"FDA Approved" is a purely Sales / marketing gimmick. Pl do not use the terms.

My recommendation is not to use any of such terms. Is it really required ?
The question comes up because medical manufacturers located outside the US and showing new systems in the US, not yet having received a 510(k) or PMA, may make contact with sales candidates from elsewhere in the world to whom they legally can make sales. This means that sales candidates from the US cannot be sure when viewing such a new system whether it is legally permissible for it to be sold to them.

Of course, sales candidates from elsewhere in the world also consider FDA clearance to be an important...often essential...credential.

So it's very common to see plain little black-and-white cards on easels or notices in the lower corners of graphic displays for new systems, especially at key buying shows like the Radiological Society of North America annual meeting, stating the systems's status.
 

Michael Malis

Quite Involved in Discussions
#6
The question comes up because medical manufacturers located outside the US and showing new systems in the US, not yet having received a 510(k) or PMA, may make contact with sales candidates from elsewhere in the world to whom they legally can make sales. This means that sales candidates from the US cannot be sure when viewing such a new system whether it is legally permissible for it to be sold to them.

Of course, sales candidates from elsewhere in the world also consider FDA clearance to be an important...often essential...credential.

So it's very common to see plain little black-and-white cards on easels or notices in the lower corners of graphic displays for new systems, especially at key buying shows like the Radiological Society of North America annual meeting, stating the systems's status.
Yes, to MIREGMGR point, it is the only way that people outside the US can separate product that legally permissible to sell vs. product that have not yet received a 510(k)...

Also, from Marketing and Sales side, I would want to separate my product that has FDA clearance from the competition that may not!

So "CLEARANCE from the FDA" statement on Marketing and Sales Literature is important!
 
W

WilliamS

#7
My feeling is this you should avoid the use or reference to "FDA" on anything, espicially literature and at Trade Shows.

You could however provide a copy of your Summary 510(k), which is publicly available on the FDA Website anyway. Then ask your competition to provide these's as well.

Also, it you see literature that says "Approved by the FDA", send a copy to FDA and let them fight your battle.
 

Weiner Dog

Med Device Consultant
#8
I totally agree. Making this claim is a violation of the FD&C Act + medical device labeling regulations. Being an ex-FDA investigator, I always collected product literature which referenced 'FDA approval'. Remember- FDA is not a company's sales tool or quality assurance department. FDA's job is to make sure that companies adhere to the applicable FDA laws and regulations. On the other hand, ISO Notified bodies want to make sure companies meet customer expectations and are capable to provide precision of a quality management system. As such, FDA's policies are public health and risk based (law enforcement) and ISO's policies are customer based.
 

Le Chiffre

Quite Involved in Discussions
#9
Thanks for the replies, but I'm really not buying it. :nope:

Take a look at this for example, under the process to register a medical device user fee, there's the question using the terminology:
"pay the fee within 30 days of FDA's approval/clearance of this device"

Sounds like FDA expect to grant their "approval/clearance" and I'd be correct in relaying this announcement to my customers :yes:
 

Attachments

M

MIREGMGR

#10
Heh. Hey, it's free advice, you don't like it, that's OK. :)

As a final thought, though, there's a voluminous public record of FDA actions against companies on this specific issue.
 
Thread starter Similar threads Forum Replies Date
M Using the phrase "herein referred to" Document Control Systems, Procedures, Forms and Templates 8
J Incoming Inspection Records using Excel File ISO 13485:2016 - Medical Device Quality Management Systems 2
J Using ring gauges General Measurement Device and Calibration Topics 2
M Load Cell Calibration using a totalizer on a flow meter General Measurement Device and Calibration Topics 0
P Can Neoprene be Cleaned Using Isopropyl Alcohol (IPA) Manufacturing and Related Processes 4
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
chris1price Sterilization using beta radiation Other Medical Device Related Standards 2
B Struggling with using the 5.6 version Ford Capacity Analysis Report APQP and PPAP 5
cnbrosa Study Type 1 on a CMM using a measuring support Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 1
D Risk Analysis using Monte Carlo Simulation instead of Scoring and Heat Map Risk Management Principles and Generic Guidelines 2
W Using tailoring guidelines to tailor a QMS procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Y We found out we have been using a equipment without validation for past 4 years Quality Manager and Management Related Issues 6
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
C Importer shell game - Using a third party logistics provider (3PL) in the EU EU Medical Device Regulations 5
S Work performed in Canada on US patients using US device Canada Medical Device Regulations 1
S Is using ANSI/ASQ Z1.4-2008 the correct sampling plan to determine Pass/Fail of Apparel measurements? AQL - Acceptable Quality Level 4
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
Tagin Evaluating nonconformances for escalation using Bayesian methods? Statistical Analysis Tools, Techniques and SPC 2
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
R Clause 7.7 Replicate, Recalibration and Intermediate checks using Artifact ISO 17025 related Discussions 1
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Unit of Use DI (Device Identifier) - Products using the same device US Food and Drug Administration (FDA) 0
A Using Arduino based sensors for Poke-Yoke Manufacturing and Related Processes 6
M Using your Manufacturer's ISO certification ISO 13485:2016 - Medical Device Quality Management Systems 5
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
B Using non CE parts in a machine CE Marking (Conformité Européene) / CB Scheme 1
G Gauge R&R on multiple dimensions using 3D measurement system Capability, Accuracy and Stability - Processes, Machines, etc. 6
A Hospital IT expectations for connected medical device using WIFI Medical Information Technology, Medical Software and Health Informatics 0
Proud Liberal Cp / Cpk on position using multiple MMC bonuses Capability, Accuracy and Stability - Processes, Machines, etc. 2
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
D Using "Particle Size Standard" templates as gauges - How to avoid giving a gauge # while using for process control? General Measurement Device and Calibration Topics 2
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
I Reducing CE marking cost using manufacturer test reports CE Marking (Conformité Européene) / CB Scheme 5
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 8
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate Qualification and Validation (including 21 CFR Part 11) 3
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate General Measurement Device and Calibration Topics 2
M Raw stock material testing discrepancy using an XRF (x-ray fluorescence) analyzer Manufacturing and Related Processes 7
Z Using FMEA for Knowledge Management FMEA and Control Plans 6
Sidney Vianna NASA to Develop a Novel Approach for All-Electric Aircraft Using Cryogenic Liquid Hydrogen as Energy Storage World News 2
S How many of you are using Robotic process automation for calibration lab management? ISO 17025 related Discussions 0
J Including Repeats in DoE using Minitab Using Minitab Software 5
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0
John Predmore What size pinhole can be reliably detected using visual inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
D I'm new in IMDS special using the IMDS application Manufacturing and Related Processes 8

Similar threads

Top Bottom