Guidance

Electronic Informed Consent (eIC): How The FDA/OHRP Final Guidance Affects You: January 29, 2019 Webinar

1/4/2019

Topic: Electronic Informed Consent (eIC): How The FDA/OHRP Final Guidance Affects You

Date: January 29, 2019

Time: 1:00 p.m. – 2:30 p.m. EST

Duration: 90 minutes

Sponsored by: Life Science Training Institute

Webinar: Live interactive session. Recording will be available for 30 days.

Sign up here.

FDA Releases Guidance on Benefit-Risk Factors in Substantial Equivalence in 510(k) Submissions

10/18/2018

A new FDA Guidance on Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics was released September 25, 2018. As devices become more complex, it becomes more difficult to determine if technological differences mean it is substantially equivalent to a predicate device. The guidance can be found on FDA’s website here.