SoftwareCPR August 2020 Newsletter has been published.  FDA news, regulatory updates, new SoftwareCPR content, software recalls, and software warning letters.Read More

Why are clinical studies necessary? Medical device clinical studies provide evidence for a PMA submission. Under 21 CFR 860.7, the FDA relies only on “valid scientific evidence” to determine whether there is reasonable assurance that a device is safe and effective. Valid scientific evidence can originate from a variety of sources, including well-controlled studies. Even...Read More