Use of FDA Cleared logo on packaging - The Elsmar Cove Quality …
Jul 25, 2018 · FDA uses a risk-based, tiered approach for regulating medical devices. FDA classifies devices according to risk. The highest-risk devices (Class III), such as mechanical …
Reference to FDA on Label or Labelling - Class II Medical Device
Apr 21, 2008 · The manager ask me if we can put a FDA logo (see attached document) on the label of immediate packaging of the device. I read the regulation (chapter about labelling, …
Using the phrase "Approved by FDA" in Marketing and Advertising …
Dec 11, 2009 · 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 …
CE and FDA Mark on same IVD/Medical Device Label
Jun 14, 2017 · The FDA will not stop you having a CE mark on your label; there is no equivalent US mark for the EU to object to. I would avoid putting the FDA logo on your product (even for …
Marketing Promotional Materials and citing FDA Approval
Nov 9, 2011 · The FDA Modernization Act of 1997 (FDAMA) however did change the previous rule to allow use of the word "approval" or "approved" in labeling and marketing of devices that …
FDA logo for marketing - The Elsmar Cove Quality Forum
Nov 22, 2021 · I have read the FDA policy and I wonder where this "FDA cleared" logo comes from. Why does it exist if we can't use it? We only use this logo on our marketing brochures I …
Labeling MR safe & MR Unsafe (magnetic resonance imaging topic)
Jan 29, 2015 · The MR safe / MR Unsafe logo and explanation is already in the Instructions for Use. Do we need to place the MR safe and MR unsafe logo on the productlabel (sticker)? And …
China Test Laboratory - What are "CMA" and "CNAS"...?
Apr 24, 2009 · The combined logo can be used only if authorized by CNAS (there will be a documented agreement between CNAS and the lab/organization). For FDA's GLP, I don't …
510 (k) clearance claim on medical device product packaging
Jul 18, 2019 · Hello all. If a medical device is 510(k) cleared, will it be possible to stay 510(k) cleared claim on the packaging of the product? Or this is a misbranding issue? Thank you.
Off-Label Use - Clarification of FDA Policy
Jun 8, 2020 · I've been trying to get a handle as to what the FDA policies are with respect to off-label use of medical devices (and drugs too, assuming the policies are similar). From the …