Hi

I was hoping someone could help me by providing a list of the Marketing or Market Penetration documents you would find in the Device Master Record (DMR) for medical Devices (oncology)

Thx Nigel

Hi

I was hoping someone could help me by providing a list of the Marketing or Market Penetration documents you would find in the Device Master Record (DMR) for medical Devices (oncology)

Thx Nigel

I am not exactly sure of your requirements, but did you have a look at this FDA werbsite which talks about Device Master Records - http://www.fda.gov/cdrh/qsr/08dmr.html ?

It gives clearly what are expected to be in the DMR, alongwith an example and a procedure.

If I go through the list, I didnot see any specific requirements for market penetration - I may be wrong.

I am not exactly sure of your requirements, but did you have a look at this FDA werbsite which talks about Device Master Records - http://www.fda.gov/cdrh/qsr/08dmr.html ?

It gives clearly what are expected to be in the DMR, alongwith an example and a procedure.

If I go through the list, I didnot see any specific requirements for market penetration - I may be wrong.

Thx I saw that too, but could not find anything specific for marketing...

its things like promo material, sales presentations, things where claims on product performance are made, I was hoping that someone had experienced this before.

I saw on the FDA web site that they do look at device/product claims and have dished out 483's for wrong claims and in worst case asked for recall. So to try and control this if it was in DMR it would be looked at prior to release.

Hi

I was hoping someone could help me by providing a list of the Marketing or Market Penetration documents you would find in the Device Master Record (DMR) for medical Devices (oncology)

Thx Nigel


Hello Nigel,

I am guessing....not knowing where you are located, would (for example) this apply to you?

http://www.fda.gov/ora/inspect_ref/igs/med_dev_mnfct/meddev21.html

I am sure you will hear from medical device experts here at The Cove.

Stijloor.

Thx I saw that too, but could not find anything specific for marketing...

its things like promo material, sales presentations, things where claims on product performance are made, I was hoping that someone had experienced this before.

I saw on the FDA web site that they do look at device/product claims and have dished out 483's for wrong claims and in worst case asked for recall. So to try and control this if it was in DMR it would be looked at prior to release.

Oh, so your question referred to the labelling requirements ?

Refer to this FDA website - http://www.fda.gov/cdrh/devadvice/3122.html

These requirements are termed as Pre market requirements.

Before marketing clearance is obtained, the manufacturer must assure that the device is properly labeled in accordance with FDA's labeling regulations. Once clearance for marketing is obtained, the manufacturer must register their establishment and list the type of device they plan to market with the FDA. This registration and listing process is accomplished by the submission of FDA Form 2891 and 2892.

Does this answer your question ?

Based in UK, but ship worlwide including USA, problem with 21CFR820 regs they are vague as far as marketing is concerned would like to hear from people who have marketing documents listed on DMR. Maybe I am taking it to far.

Would it be acceptable to just reference marketing documents for Product Idea Desriptions, Commercial Requirements, Department Operating Systems, Control of promo material etc etc, and the the question arises what belongs in DHR (Device History Record) and what belongs DHF (Design History File) from a marketing perspective....

Think I need a coffee and chocolate and re-think after my brain has been fed...

Based in UK, but ship worlwide including USA, problem with 21CFR820 regs they are vague as far as marketing is concerned would like to hear from people who have marketing documents listed on DMR. Maybe I am taking it to far.

Think I need a coffee and chocolate and re-think after my brain has been fed...

Hi,

In fact, the FDA website is rich with information. You need to patient in searching thru the www.fda.gov ;)

I suggest take a Starbucks coffee and things will be more clearer :bonk:

thx I will take your advice and go surfing in starbucks... just need to convince my boss it a worthy cause.

Will spend a bit more time in FDA web portal cheers

thx I will take your advice and go surfing in starbucks... just need to convince my boss it a worthy cause.

Will spend a bit more time in FDA web portal cheers

Do not get frustated :frust: in case you do not get anything

Come back to the cove in case of any further questions :bigwave:

It's all your marketing documents related to the product.

Hi. I worked as an FDA investigator (Level II Certified International Medical Device Investigator) for over 21 years- primarily in the medical device arena. Currently, I am a contract international medical device consultant for hire.

Are these marketing documents packaged with each device to customers? if so, then they constitute labeling (and were probably a design output if the device was subject to design controls) and have to be approved and controlled like other labeling and packaging.

However, if your firm does not consider these documents to be product labels, your regulatory affairs department should look over them to see if they comply with your 510(k) or PMA labeling.

If the marketing department makes unapproved claims without going through regulatory affairs, your device could be misbranded or adulterated under the FD&C act. This means, if your product was a class I exempt device (thus requiring you only to comply with the record keeping, complaint, and MDR sections), these marketing claims turn your device into an unapproved class III product. FDA CDRH has issued many warning letters to companies due to improper claims made via internet or marketing materials.

Hi. I worked as an FDA investigator (Level II Certified International Medical Device Investigator) for over 21 years- primarily in the medical device arena. Currently, I am a contract international medical device consultant for hire.

Are these marketing documents packaged with each device to customers? if so, then they constitute labeling (and were probably a design output if the device was subject to design controls) and have to be approved and controlled like other labeling and packaging.

However, if your firm does not consider these documents to be product labels, your regulatory affairs department should look over them to see if they comply with your 510(k) or PMA labeling.

If the marketing department makes unapproved claims without going through regulatory affairs, your device could be misbranded or adulterated under the FD&C act. This means, if your product was a class I exempt device (thus requiring you only to comply with the record keeping, complaint, and MDR sections), these marketing claims turn your device into an unapproved class III product. FDA CDRH has issued many warning letters to companies due to improper claims made via internet or marketing materials.

Thx GeoChaz

We are class 2 medical device, (oncology)... The literature is for mkt penetration and used by sales so the content is approved via Reg Affairs prior to issue... and they do form part of the DMR. I am aware of CDRH warning letters and we use these to beat up marketing from time to time to keep them aware of the regs required. This literature is not sent with the device so does not form part of our label copy, really the question is from a FDA perspective what they would look for within a mkt penetration group. In terms of 820, specific clauses would be good.

thx for your reply again

Thx GeoChaz

This literature is not sent with the device so does not form part of our label copy, really the question is from a FDA perspective what they would look for within a mkt penetration group. In terms of 820, specific clauses would be good.


From my experience with marketing people, 21 CFR 801.4 Meaning of intended uses and 21 CFR 801.6 Medical devices; misleading statements:bonk:

I often audit the Marketing Department immediately after interviewing the Regulatory Affairs staff.

The expressions of pain that often start to roll across the faces of the audit guides are priceless....:lol:

I often audit the Marketing Department immediately after interviewing the Regulatory Affairs staff.

The expressions of pain that often start to roll across the faces of the audit guides are priceless....:lol:

Nice one, Roland :lmao::lmao: