USFDA - Deadline for Registration and Listing of Medical Devices Manufacturers...

It’s registration and listing time!  All medical device establishments are required to pay the annual registration user fee and re-register their establishments by December 31, 2014.

FDA’s Center for Devices and Radiological Health (CDRH) has a new  tutorial that explains how to register a domestic establishment for the first time in the FURLS (FDA’s Unified Registration and Listing System)/Device Registration and Listing Module (DRLM).  

You can access this tutorial and other registration and listing tutorials through the CDRH Learn website under the “Start Here/The Basics!” section. 

USFDA CFSAN - FDA Published Updated Guidance for Industry on Food Facility Registration...

The Food and Drug Administration is announcing the availability of a guidance for industry entitled "Questions and Answers Regarding Food Facility Registration (Sixth Edition)."  The guidance includes one new  question and answer in addition to the questions and answers in the Fifth Edition of the guidance document, which is being added in light of an ongoing rulemaking under the FDA Food Safety Modernization Act (FSMA) that proposes to make certain changes to the definition of the term “farm” in 21 CFR 1.227.  

The new question and answer explains FDA’s policy regarding food facility registration for farms that also pack or hold raw agricultural commodities grown on a farm under different ownership and that would no longer be required to register if the proposed amendments to the “farm” definition are finalized as proposed in the rulemaking. Under this policy, as discussed in the guidance, FDA does not intend to prioritize enforcing the registration requirement for such establishments.  This policy is a less burdensome policy consistent with the public health.  FDA intends to make further updates to this guidance once certain FSMA rulemakings are final in order to make sure questions and answers, key terms, and definitions are consistent and accurate with regard to the registration of food facility requirements.

For more information:

Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Sixth Edition)

Federal Register Notice of Availability: Questions and Answers Regarding Food Facility Registration (Sixth Edition); Guidance for Industry

USFDA will host a webinar and Q&A Session on “How to use CDER Direct to submit Registration and Listing Structured Product Labeling (SPL) files”.

On Tuesday September 16, 2014 at 1:00 pm EDT, CDER SBIA will host a webinar and Q&A session entitled “How to use CDER Direct to submit Registration and Listing Structured Product Labeling (SPL) files”. This webinar will provide a brief demo of CDER Direct, a new software application to assist companies in submitting drug registration and listing submissions.

  

To register for this Event, please go the following link: https://collaboration.fda.gov/sbia0916/event/registration.html

(Registration password needs to be 8 characters and alphanumeric)

Note: Your registration acknowledgement will include the webinar access link. 

Audio will broadcast from your computer speakers. Please mute your microphones (to reduce audio feedback) during the webinar.

Closed captioning will be provided.

Please note: There is a user capacity limit for this webinar. For those who cannot enter the webinar, please know that it will be recorded and a link will be posted to this page:  

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm070334.htm

Questions/Comments can be submitted live via a Q/A chat window.

For questions concerning the webinar, please contact CDER SBIA at:  (866)-405-5367 | (301)-796-6707 

CDER SBIA webinar series: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm070334.htm