Medical Devices

CDRH Outreach Emails

The CDRH Outreach Email Program is a resource for the Center for Devices and Radiological Health (CDRH) to send timely communications to external stakeholders on a variety of hot topics. 

Emails are generally targeted to a specific stakeholder group, for example:

  • consumers
  • associations (typically professional organizations or healthcare professional organizations)
  • manufacturers

CDRH Outreach Emails

The following is a listing of recent outreach emails issued by CDRH. Emails will generally remain on this table for 6 months after the date it was posted, and then be removed:

DateSubjectAudience
04/15/16 FDA Issues a Final Order to Reclassify External Pacemaker Pulse Generator (EPPG) Devices Industry
03/29/16 Announcing Five New Unique Device Identification (UDI) Education Modules Registered Firms; Associations; Industry
03/17/16 Update to Final Guidance Document: “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" Industry
03/11/16 FDA/CDRH Seeks Participants for the 2016 Experiential Learning Program (ELP) Registered Firms; Associations
03/09/16 FDA Issues Proposed Rule to Classify Posterior Cervical Screw Systems Industry; Associations
03/04/16 Public Docket for Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers Industry; Associations
03/04/16 FDA Issues Draft Guidance on IDEs for Neurological Devices Targeting Disease Progression and Clinical Outcomes Industry; Associations
03/02/16 FDA Issues Two Proposed Orders to Reclassify Blood Lancets Registered Firms; Industry; Associations
01/01/16 Announcing Draft Guidance on Public Notification of Emerging Postmarket Medical Device Signals CDRH Industry; Device Associations; Consumer Associations
12/31/15 Announcing Draft Guidance on Unique Device Identification: Convenience Kits Registered Firms; Device Associations; UDI and GUDID Subscribers
12/28/15 FY 2016 Proposed Guidance Development and Focused Retrospective Review of Final Guidance Industry; Associations
12/14/15 CDRH Industry: FDA Final Guidance for Devices to Treat Glaucoma Industry; Consumers
12/08/15 Announcing Final Guidance on Gowns Intended For Use in Health Care Settings – Webinar January 21, 2016 Industry; Consumers
10/02/15 Functional Equivalence of Transition Tyvek Registered Firms; Associations; Industry
09/15/15 Announcing Seven New Medical Device Education Modules
07/01/15 Final Guidance on Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements Industry
06/26/15 Announcing Draft Guidance on Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings Registered Firms
06/25/15 Announcing Draft Guidance on Unique Device Identification: Direct Marketing of Devices Industry; Associations; GUDID and UDI Users

We encourage you to periodically check this page for new communications sent by CDRH.

Contact FDA

1-800-638-2041
301-796-7100
CDRH-Division of Industry and Consumer Education (DICE)

Office of Communication and Education

Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Page Last Updated: 04/19/2016
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