Kevin has hit the key points. Never let Marketing go outside your On Label indications for use. If you have different indications in different jurisdictions, you need to track the claims and their associated marketing materials by area.
I recommend you use a tracking spreadsheet for each claim. Match each claim to the IFU or the regulatory filing that supports it. You may want to separate the claims into categories like "technical claims" (generally these are backed by your V&V testing or are self-evident from the design specifications) and "clinical claims" (backed by journal articles or clinical study documents).
Any clinical claims evidence that is new must be incorporated into your CER at the next revision.
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Ian Broome, M.S., RAC
Needham, MA
United States
***Any posts or activity shared on RAPS Forums are my own personal views; I do not speak on behalf of Boston Scientific Corporation (BSC).***
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Original Message:
Sent: 25-Jan-2023 13:12
From: Kevin Randall
Subject: Claims
While there can be jurisdictional nuances, the general rules for Regulatory when reviewing and helping to develop product claims are to assure that:
- the claims are not false or misleading in any particular,
- the claims don't exceed or conflict with the cleared/approved intended use and any indications for use, and
- objective, scientifically-valid data are available which substantiate the claims; such data are generally first established as part of the premarket clearance/approval process certainly, but are often supplemented with additional data later.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 24-Jan-2023 15:54
From: Anonymous Member
Subject: Claims
This message was posted by a user wishing to remain anonymous
I need guidance on how regulatory is typically involved in developing claims. I've been asked to review current literature on a material that we use in a key product line. The literature is from the manufacturer and from professional research journals. I've been asked to propose claims that we can use in our marketing efforts. I've never been involved in this process and would appreciate any guidance on what should be avoided.