Use of FDA Cleared logo on packaging
2018年7月25日 · I saw that and read through it. They aren't putting the fda logo per that policy on the box. they are putting FDA cleared per attached pic. it's still a class I exempt device though …
Reference to FDA on Label or Labelling - Class II Medical Device
2008年4月21日 · The manager ask me if we can put a FDA logo (see attached document) on the label of immediate packaging of the device. (To tell the truth, he asks me a lot of question and …
FDA logo for marketing - The Elsmar Cove Quality Forum
2021年11月22日 · Warning Letters have been issued for the use of FDA logo. Silkprousa LLC - 608493 - 08/18/2020 | FDA USH Diagnostics, Inc./covidinstanttest.net - 612084 - 07/09/2021 | …
CE and FDA Mark on same IVD/Medical Device Label - The Elsmar …
2017年6月14日 · 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 …
Marketing Promotional Materials and citing FDA Approval
2011年11月9日 · 3. "Cleared" is very general, because it means that all applicable requirements have been met to an extent that satisfies / would have satisfied the FDA (i.e. the General …
Using the phrase "Approved by FDA" in Marketing and Advertising …
2009年12月11日 · This is obviously a no-no. I'm looking at submitting a 510(k) application soon and have got used to seeing the term "FDA Approval" in marketing and advertising material. …
Marketing Promotional Materials and citing FDA Approval
2011年11月9日 · The FDA Modernization Act of 1997 (FDAMA) repealed the restriction in Section 301(l) of the Federal Food, Drug and Cosmetic (FFD&C) Act, which prohibited reference to …
Medical Device Labeling: Rx Only - Elsmar Cove Quality and …
2010年9月20日 · I prefer to avoid using the "USA-centric" wording since risk knows no boundaries. Also, as you are probably aware, the FDA (per guidance) allows "Rx Only" in lieu …
Does a dental handpiece need FDA permission? - The Elsmar Cove …
2010年1月22日 · Here is the FDA definition (to make sure what I'm referencing is what you are describing): A dental handpiece and accessories is an AC-powered, water-powered, air …
Labeling MR safe & MR Unsafe (magnetic resonance imaging topic)
2015年1月29日 · FDA also recognizes four ASTM standards--F 2503, F 2119, F 2213 and F 2052--that call for MRI devices and accessories to be evaluated by means of testing or …