BioPhia Consulting Inc.
BioPhia Home
About
The Team
Services
Media
Regulatory
May, 2016
June, 2016
September, 2016
November, 2016
February, 2017
March, 2017
August, 2017
September, 2017
Blog
RSS
CDER Updates March/April 2017
6/2/2017 1:43:19 PM

 

 

Update to Guidance

Section I. Introduction

• Paragraph added describing rationale for changing timetable for required master file submissions in eCTD from 24 months to 36 months.

Section III.B. Timetable for Implementation of Electronic Submission Requirements

·         Updated to reflect that the requirement for master files to be filed electronically takes place 36 months after May 5, 2015.

Example of timetable updated to reflect actual timetable for the implementation of the electronic submissions requirement.
CBER Updates March/April 2017
6/2/2017 1:41:18 PM

 

 

 

 

The Food and Drug Administration (FDA) issued a final rule, Use of Symbols in Labeling, June 15, 2016, that became effective September 13, 2016. The final rule permits the use of symbols in all medical device labeling without adjacent explanatory text (referred to as "stand-alone symbols") if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. The final rule seeks to harmonize the U.S. device labeling requirements for symbols with international regulatory requirements.

Below is a list of resources on the use of symbols in labeling:

·         Final Rule: Use of Symbols in Labeling

·         Frequently Asked Questions

FDA Voice: Using Symbols to Convey Information in Medical Device Labeling
CDRH Updates - March/April 2017
6/2/2017 1:38:02 PM

·         Presentation (WMV - 11.4MB)

·         Printable Slides (PDF - 273KB)

·         Transcript (PDF - 155KB)

§  Presentation (WMV - 19.5MB)

§  Printable Slides (PDF - 937KB)

§  Transcript (PDF - 274KB)

§  Case Study: Using the De Novo Process to Classify and Bring to Market an Innovative, Low-to-Moderate Risk Device (PDF - 504KB)

 

SUMMARY: The Food and Drug Administration (FDA or Agency) has  identified a list of class II devices that, when finalized, will be  exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment. Submit either electronic or written comments on the notice by May 15, 2017. 

 

SUMMARY: The Food and Drug Administration (FDA or Agency) has  identified a list of class I devices that are now exempt from premarket  notification requirements, subject to certain limitations. FDA is  publishing this notice of that determination in accordance with  procedures established by the 21st Century Cures Act.
 
3 items total
BioPhia Home
About
The Team
Services
Media
Blog