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:

10/14/16 Electronic Submission of Labeling for Certain Home-Use Medical Devices Proposed Rule Registered Establishments; Associations; Industry
09/28/16 FDA Updates Expedited Access Pathway (EAP) Program Website All Registered Firms; CDRH Industry; Industry Associations
09/20/16 Draft Guidance on “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices” Industry
09/20/16 CDRH Issues 2017 Regulatory Science Priorities Industry
09/09/16 FDA Issues Draft Guidance for 510(k) Third Party (TP) Review Program Registered Establishments
08/01/16 Important Information on Medical Device User Fees for Fiscal Year 2017 (October 1, 2016 through September 30, 2017) Registered Establishments
07/28/16 Announcing the General Wellness: Policy for Low-Risk Devices Final Guidance and Webinar on September 1, 2016 Industry
07/27/16 FDA Issues Final Order: "Reclassification of Iontophoresis Devices Intended for Any Other Purposes” Registered Establishments; Industry
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07/26/16 Draft Guidance on the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Industry Representatives
06/17/16 “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” Draft Guidance Registered Establishments; Industry
06/15/16 FDA Issues Draft Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions Industry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
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

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

Contact FDA

1 (800) 638-2041
(301) 796-7100
Information-Medical Devices / Radiation Products

Division of Industry and Consumer Education

CDRH-Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Page Last Updated: 10/17/2016
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