We try to get fda approval for hirudin blood collection tube, a blood collection tube use hirudin as universal anticoagulant. Based on our knowledge, there is no such a similar product in current us medical market (we understand this may be a hurdle). We are looking for help and guide to obtain fda approval+11 Other Responses
I have a product which is a gel that treats wounds, burns, and type 2 diabetic cracked skin. This has a ec mark in europe and is a 2b medical device. I have all of the microbiology reports and would like to know how to proceed towards fda approval. The product is completely natural and is comprised of oxygen and seawater. I also saw there was a no classification option under fda under wound kit without drugs. This would be excellent for both otc as well as hospitals. Can someone please tell me how to proceed.+13 Other Responses
i am a quality assurance manager of one of the biggest pharmaceutical company in turkey.
I am looking for a fda compliance consulting company to assist us for fda approval process.+19 Other Responses
i am looking for assistance in getting a few items fda approved. I have detox patches, a reflexology machine and a foot/leg massager. I am near los angeles and will be able to bring our products there if need be.
Many thanks in advance for your email!
ashley+5 Other Responses