what are the clinical trial phases for medical devices?

Question

drug clinical trials go from phase I to IV, are the phases for clinical testing of a medical device the same? if you have any information on relevant websites for testing and trial phases of a medical device i would really appreciate it.

its for a device that would theoretically take body fluid samples (blood).

Answer 1

The first phase is a test on a small group of healthy volunteers. It usually takes a couple of months and will involve double blind trials (where neither the patient nor the staff know which is the drug and which is the placebo). It usually takes about 3 months to get through phase 1.

The second phase is also on a small group of people, but will contain people sufering from the disease the medicine is expcted to cure. It will take 6-12 months to do all the Phase 2 trials.

Phase 3 is where the drug is tested in a large group (many thousands) of all ages, whether healthy or ill. This phase takes 3-5 years to clear. And then you can get into phase 4...

The whole process will take between 5 and 10 years, and cost about £100 million pounds. If the drug fails at any stage then you can't continue with that drug. Only about 1-2% of drugs that go into phase 1 trials will pass phase 4.

If you want more info on this, then I would suggest looking at the FDA website. Or a pharmaceutical companies website (eg. Bayer, Pfizer) etc.

The trial for a new device is a lot less strenuous, as the drug has already passed. However, if it is an invasive technique their will still be some rigorous testing.

Answer 2

I think it depends on the device. It might vary if it is used on a human body, inside a human body during a procedure, implanted (temporarily or permanant) inside the human body. There is a long list of formal testing that needs to be done to satisfy the FDA and similar agencies in Europe and Japan.

Answer 3

Epidemiology is a branch of drugs that analyze how epidemics take place, how an organism spreads, how people behave in a virulent disease, and appropriate subjects. The epidemiology of a particular ailment is each and all the data that somebody learns with regard to the ailment or the circumstances it has brought about. you could learn the epidemiology of a ailment even nevertheless it hasn't brought about a virulent disease; you're basically attempting to discover out the way it spreads - vectors, possibility factors, mortality expenditures, etc.