Requirements for "Claims Guide" for medical devices

SGquality

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#1
Has anyone heard about "Claims Guide" for medical devices? I wanted to know what should be the contents and where can I find the regulatory requirements.
 
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William55401

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#2
Are thinking about labeling claims? If so, there is guidance (and law) out on the internet. What market is of interest? Please be more specific. TY
 

SGquality

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#3
Yes, claims as it relates to labeling content. But my question was around the documentation of these claims in a record called named "Claims Guide". Do you have such record and if yes, what should be the contents and if this is a regulatory expectation?

Thanks!
 

William55401

Involved In Discussions
#4
This helps. Most orgs have a label review procedure to ensure items meet statutory requirements (assuming USA market, see partial screen grab below that includes some CFR cites for labeling) that include claims. Other firms call it label review and treat is a a design verification activity with a protocol and a report. Dont' overthink the form. For claims? Two columns. 1. The marketing / labeling claim. 2. Objective evidence.
Screen Shot 2020-06-12 at 11.17.50.png
 

SGquality

Quite Involved in Discussions
#6
This helps. Most orgs have a label review procedure to ensure items meet statutory requirements (assuming USA market, see partial screen grab below that includes some CFR cites for labeling) that include claims. Other firms call it label review and treat is a a design verification activity with a protocol and a report. Dont' overthink the form. For claims? Two columns. 1. The marketing / labeling claim. 2. Objective evidence.
Thanks for your response. Yes, this is for US market. Similar to the DV approach of a protocol and report, our company decided to have it as a standalone document, called "Claims Guide" which is part of the DV activity.

Another follow-up question on handling or control of marketing assets - do they have to include a reference to the claims?

To give some background, a consultant told us that all marketing materials (that includes Market Community Asset, Foundational Assets, and Additional Assets) need to have a reference with the Claims Guide document so we have included the Claims Guide number and revision of that document in each of the marketing material.

Is this referencing of the Claims Guide (with doc. no and rev) required?
 
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