Conference on Latest FDA Proposed Changes to the Process

September 22, 2016
September 23, 2016
Seattle, WA
US
Phone:8004479407
Toll Free:8004479407

"Bullet Proof 510(k) and Latest FDA Proposed Changes to the Process" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

This two-day course is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions.

More Events
Upcoming event
PMA Foodservice Conference and Expo
July 24, 2020July 25, 2020
Upcoming event
SCOPE
August 23, 2020August 25, 2020
Upcoming event
CSCMP Edge
September 20, 2020September 23, 2020
Upcoming event
Cold Chain Conference & Expo
September 28, 2020September 30, 2020
Upcoming event
Grocery Delivery Connect
October 7, 2020October 9, 2020
Upcoming event
National Frozen & Refrigerated Foods Convention
October 17, 2020October 20, 2020
Upcoming event
IFDA - Distribution Solutions Conference
October 25, 2020October 28, 2020
Upcoming event
CEBA Conference & Expo
November 10, 2020November 12, 2020
Upcoming event
TPM 2021
February 28, 2021March 3, 2021
Upcoming event
ProMat
April 12, 2021April 15, 2021