Use of FDA Cleared logo on packaging - The Elsmar Cove Quality …
Jul 25, 2018 · I have a customer who just added an "FDA Cleared" logo to their product box. we are the mfg. of said product which is classified as follows: Description: Exerciser, non-measuring Product code: ION Device Class: 1 Regulation No...
Reference to FDA on Label or Labelling - Class II Medical Device
Apr 21, 2008 · I read the regulation (chapter about labelling, misbranding) and I can't decide if we can or not put this logo on the packaging or in the instruction manual accompanying the device. What can we do in order to communicate about the fact that the FDA permits our medical device to be marketed in US?
FDA logo for marketing - The Elsmar Cove Quality Forum
Nov 22, 2021 · We only use this logo on our marketing brochures I read that the "FDA seem to “close their eyes” to companies using “FDA registered” of “FDA cleared” on their company websites and product advertising.
Labeling MR safe & MR Unsafe (magnetic resonance imaging topic)
Jan 29, 2015 · We would like to start selling our MR safe and MR unsafe devices in the USA and are writing the 510(k). 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 also on the box...
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 think CNAS is able and willing to do that.
Interesting Discussion - FDA 510 (k) required? US company Private ...
Feb 12, 2005 · Re: FDA 510 (k) required? US company private labeling a FDA class II device Is the company that is buying products and private labeling required to put the manufacturers name on the label under Manufactured by and their name under Distributed by?
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 "FDA Approved" for use in advertising and marketing?
CE and FDA Mark on same IVD/Medical Device Label - The Elsmar …
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 sale in the US); it is meaningless at best and a regulatory risk at worst
Medical Device Labeling: Rx Only - The Elsmar Cove Quality Forum
Sep 20, 2010 · We plan on introducing a class III medical device to the US. With regards to labeling, "Rx only" should be on the label. My question is on which labels should it be? We'd have an "X-pack" with X devices inside. Is it enough to have the "Rx only" on the global packaging (the box with the X...
Concession Procedure FDA Guidelines - medical devices.
Jul 5, 2005 · Hi, Can anyone tell me if a 'concession procedure' can be called by any other name? Can the procedure also be written within the 'non conforming product procedure, or does it have to be a procedure in it's own right? thankyou in anticipation.