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 so according to what i read, it wouldn't be "fda cleared" & being the mfg that is shipping these to the distributors, we aren't comfortable using these boxes.

2009年12月11日 · Remember- FDA is not a company's sales tool or quality assurance department. FDA's job is to make sure that companies adhere to the applicable FDA laws and regulations. On the other hand, ISO Notified bodies want to make sure companies meet customer expectations and are capable to provide precision of a quality management system.

2017年6月14日 · It is not OK to indicate "FDA approved" - this is considered misbranding according to FDA guidance. See HHS Publication FDA 89-4203 Labeling Regulatory Requirements for Medical Devices (go to the section starting on page 4 entitled False or Misleading Labeling, particularly the second paragraph).

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 I cannot answer it) 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 ...

2011年11月9日 · Only PMA devices can be approved. 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 Controls and the Special Controls, for a class II device). As far as I'm aware the FDA doesn't approve of manufacturers using the FDA logo at ...

2008年11月3日 · For the list of FDA approved manufacturing facilities for medical devices, go to the CDRH - Registration and Listing Database and enter INDIA under "Establishment Country". You could further filter using "Establishment Type" to get specific data.

2013年2月19日 · Hi All I have a newbie question on approving documents. Within the framework of the FDA QSR (part 820), if I am the author of a document and have the document reviewed by another department head, can I then also be the person who finally approves the …

2011年11月9日 · The FDA Modernization Act of 1997 (FDAMA) repealed the restriction in Section 301(l) of the Federal Food, Drug and Cosmetic (FFD&C) Act, which prohibited reference to FDA approval in the labeling or advertising of medical devices that have an approved PMA or IDE.

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 | FDA Also refer to FDA in Brief: FDA Calls on Certain Firms to Stop Producing and Issuing Misleading “FDA Registration Certificates”

2011年6月20日 · Please kindly clarify for me... Performer, verifier, reviewer & approver signatures on a quality record are a good documentation practice...Probably not all entries would need to be verified and/or reviewed and/or approved. But certainly there …