Medical Device Pre-Selling and Conference Posters while awaiting Approval

G

GPjeri

#1
Does anyone know where the line is for "pre-selling" if you create a poster for a conference while awaiting approval of your medical device? I know you have to post signage that says the product is not approved for sale in the US, and avoid claims but I'd appreciate any additional info.
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Does anyone know where the line is for "pre-selling" if you create a poster for a conference while awaiting approval of your medical device? I know you have to post signage that says the product is not approved for sale in the US, and avoid claims but I'd appreciate any additional info.
Any Medical Device experts that can help?

Thank you!!

Stijloor.
 

RA Guy

Involved In Discussions
#3
I attended a seminar given by a law firm well versed in FDA compliance several years ago and some of the guidance they gave included not soliciting or accepting orders.
In other words FDA draws a line at pre-selling.

You are right about not making claims although I've generally been comfortable for sales and marketing to discuss the general application the product is planned to address and when it might be released for sale (pending FDA clearance or approval, of course).

Also recommended to keep any displays somewhat discreet as at many trade shows, etc. FDA is walking the floor. The more prominent the display, the more likely it would receive negative attendtion from FDA.

There is really very little in the way of guidance in this area to my knowledge.
 

Rocke

Involved In Discussions
#4
The FDA has a compliance policy guide which adresses the issue (vaguely).

"Although a firm may advertise or display a device that is the subject of a pending 510(k) -- in the hope that FDA will conclude that the device is substantially equivalent to a pre-amendments device -- a firm may not take orders, or be prepared to take orders, that might result in contracts of sale for the device unless limited to research or investigational use."

But I have not been able to get a more specific interpretation.

http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073888.htm
 
Thread starter Similar threads Forum Replies Date
M Informational Health Canada guidance document – Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
M Medical Device News Health Canada – Consultation: Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
B Manufacturing site relocation of pre amendment Class II medical device Manufacturing and Related Processes 4
K Harmonisation of Global Medical Device Pre-Market Regulations Other Medical Device Regulations World-Wide 5
F Definition Medical Device Contract Manufacturing PAI (Pre-Approval Inspection) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
J Pre-Revenue Medical Device Company ISO 13485 Audit ISO 13485:2016 - Medical Device Quality Management Systems 1
W Pre-packaged quality systems - Class IIa Medical Device EU Medical Device Regulations 27
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
S Medical Device MRI Compatibility EU Medical Device Regulations 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
M Medical device substance based-leachables Other Medical Device Related Standards 2
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2

Similar threads

Top Bottom