"Important aspects to note when it comes to Goals:
http://www.spring.org.uk/2011/03/11-goal-hacks-how-to-achieve-anything.php"
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(510k) FDA Approval, can it be failed???
4 Replies
Hello there,I hope there are some people on this forum that have some experience with FDA approvals... I am working with an American company that is busy trialing a device that is going to be used in…Continue
Started this discussion. Last reply by Marius van Niekerk Aug 25, 2011.
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Laurence Sachs commented on Jacques van Heerden's blog post 5 Tips for Setting Up Your Goals in Life
Marius van Niekerk replied to Laurence Sachs's discussion (510k) FDA Approval, can it be failed???"Hi Laurence,
Yes, it can definitely be failed.
It's been a while since I worked with them but:
Depending on the device and where it is going to be used (Class of use, risk), some possible fails include:
If it to be used…"
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Herman Taljaard replied to Laurence Sachs's discussion (510k) FDA Approval, can it be failed???"Hi Laurence, products would fail for any number of reasons. The FDA's mandate is to ensure that consumer products are safe for human consumption and use. If they feel that there is any risk that a product would be unsafe for…"
Laurence Sachs replied to Laurence Sachs's discussion (510k) FDA Approval, can it be failed???"Thanks for your reply Herman!
Why would a product fail?
Laurence"
Herman Taljaard replied to Laurence Sachs's discussion (510k) FDA Approval, can it be failed???"Hi Laurence,
Products can fail the FDA approval process - many products "died" as a result of not obtaining FDA approval. Their process is tedious, time consuming and difficult to navigate, especially where it relates to…"
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