Date:
Thursday, April 14, 2022 – 11:00 to 12:00
Location:
Virtual
Summary Sentence:
What’s required by FDA to get into an IDE trial: Hint: robust design history files, and answers to questions that validate or confirm clinical hypotheses.
Investigational Device Exemptions are required by the U.S. FDA for devices or technologies that require clinical use before regulatory approval or general market release. Examples of devices that may require an IDE study are first in human devices, devices that require Class III premarket approvals, some Class II devices, or a de novo device or technology that requires human use data to meet regulatory requirements.
Url:
https://us02web.zoom.us/webinar/register/WN_wGNZ4dszQMaq2slJPT7VMA?utm_medium=email&_hsmi=207596030&_hsenc=p2ANqtz–MeyrspYf_8hdTX1NwhTaIQrlxTqyb5T8aZwfr8aNd9oDNi2VFuoKQGkyCMgnIUzxMT8AdgC0M13vSzKiJXloUC_VSCQ&utm_content=207596030&utm_source=hs_email
Event Categories:
Invited Audience: