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Workshop | Virtual

Event Title
Virtual Public Workshop – Accreditation Scheme for Conformity Assessment Expansion - April 17, 2024
April 17, 2024


Date:
April 17, 2024
Time:
11:00 AM - 1:00 PM ET

The Food and Drug Administration (FDA) is announcing a virtual public workshop to discuss with stakeholders approaches to expand the Accreditation Scheme for Conformity Assessment (ASCA) program. The ASCA program is designed to streamline conformity assessment aspects of medical device review. Currently, ASCA-eligible standards include standards and test methods from the basic safety and essential performance and biocompatibility series. The FDA is requesting stakeholders share their perspectives and priorities regarding potential expansion of the program. 

DATE and TIME

This workshop will be held on April 17, 2024 from 11:00 a.m. to 1:00 p.m. (ET) by webcast only. 

WEBCAST

The public workshop will be webcasted, and if you register, the link will be provided in your confirmation email. The link for the archived webcast will be posted to the webpage for viewing after the workshop. 

PRELIMINARY AGENDA

The following public workshop agenda is preliminary and subject to change. More information will be made available as the agenda is confirmed.

Time Subject Name of Speaker
11:00-11:15 a.m. Introduction and agenda Eric Franca, Ph.D.
11:15-12:45 p.m. 

Discuss ASCA expansion topics:

Aspects of how the current set of ASCA standards worked well or could have worked better during the pilot phase

Approaches to consider for ASCA expansion, e.g., options such as leveraging existing conformity assessment schemes, adding new standards or test methods

New technical areas appropriate to consider adding to the ASCA program

Question and Answer

Eric Franca, Ph.D
12:45-1:00 p.m.  Summary and concluding remarks Eric Franca, Ph.D

REGISTRATION

If you wish to attend this public workshop, you must register by 4:00 p.m. on April 16, 2024 at, https://fda.zoomgov.com/webinar/register/WN_sBpt2mPaSTCd8xPVIdxFEA.
  
There is no fee to register for the public workshop. When registering, you must provide the following information: 

(1) Name 
(2) Title 
(3) Affiliation, Company or Organization
(4) E-mail address 
(5) Stakeholder Category (Academia, Clinician, Consultant, Government, Industry, Regulatory and Other) 

Registrants will receive confirmation when requests for registration have been processed.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, Susan.Monahan@fda.hhs.gov.

COMMENTS

Please submit your comments regarding the workshop to Regulations.gov, Docket No. FDA-2024-N-0645 by May 17, 2024.    

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is received.  

The resulting discussions from the workshop and comments received in the docket will be taken into consideration.

CONTACT

For questions regarding workshop content please contact:

Gail Rodriguez
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Gail.Rodriguez@FDA.HHS.GOV

 
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