Erkang Ai, Ph.D.

Erkang Ai, Ph.D.

Hogan Lovells

Contact
View Bio
RSS

Latest Posts › FDA Approval

Share:

Paving the way for product authorization: FDA proposes rule to reclassify medical image analyzers

On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes medical imaging from class III (premarket approval) devices to class II (subject...more

6/19/2018  /  FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Medical Software , Pharmaceutical Industry , Proposed Rules , Regulatory Oversight , Regulatory Requirements

FDA’s Software Pre-Cert Program: More Details Revealed

In follow up to the U.S. Food and Drug Administration’s (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot Software Precertification (Pre-Cert) program, the Agency held an August 1, 2017,...more

8/10/2017  /  21st Century Cures Initiative , Digital Health , FDA Approval , Food and Drug Administration (FDA) , International Medical Device Regulators Forum (IMDRF) , Medical Devices , Medical Software , Regulatory Standards
2 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide