FDA CDRH Washer/Disinfector 510(k) Draft Guidance

FDA CDRH “Guidance On the content and format of Premarket Notification 510(K) Submissions Of Washers and Washer/Disinfectors” draft for comment Issued August 4,1998. Section K addresses software documentation requirements for ventilator submissions by indicating the the general software submission guidance applies and the software should be considered of “Moderate” concern. This is a change from the guidance issued in 1993 which considered it of major concern. Note, however, that this 1998 version is a draft document.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT

Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.