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
07/27/16 Final Guidance Document: “Adaptive Designs for Medical Device Clinical Studies” Registered Establishments; Associations; Industry
07/26/16 Draft Guidance on the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Industry Representatives
06/17/16 “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” Draft Guidance Registered Establishments; Industry
06/15/16 FDA Issues Draft Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions Industry
06/13/16 FDA Implements Administrative Changes for Modular Premarket Approval Applications (PMAs); Effective June 13, 2016 Industry; Class lll Registered Establishments
05/23/16 FDA Update to CDRH Learn Module on Early Feasibility Studies Industry; Registered Firms
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
03/04/16 FDA Issues Draft Guidance on IDEs for Neurological Devices Targeting Disease Progression and Clinical Outcomes Industry; Associations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

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: 07/27/2016
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