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
05/15/17 FR Notice: Request for Comments on FDA Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program Industry
04/13/17 CDRH Industry: Class I Device Types Exempt from Premarket Notification Industry; Associations
03/23/17 FDA Announces the 2017 CDRH Experiential Learning Program (ELP) Registered Manufacturers
01/13/17 FDA Makes Correction to Compliance Date for Reclassification of Thoracolumbosacral Pedicle Screw Systems Industry
01/12/17 Webinar - Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance - February 23, 2017 Industry
01/09/17 FDA Bans Powdered Surgeon Gloves; Powdered Patient Examination Gloves; Absorbable Powder for Surgeon’s Glove Registered Establishments
01/05/17 FDA Reclassifies Surgical Instrumentation For Use With Urogynecologic Surgical Mesh From Class I to Class II Registered Manufacturers
01/03/17 CDRH Industry: CDRH to Post Early Notification of Recalls Industry
12/29/16 Webinar - Final Guidance on Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types Industry
12/29/16 FDA Final Guidance and Webinar on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions Industry; Consumers
12/27/16 FY 2017 Proposed Guidance Development and Focused Retrospective Review of Final Guidance Industry; Associations
12/27/16 FDA Issues Final Guidance on Postmarket Management of Cybersecurity in Medical Devices All Health Care Providers/Professionals, Industry, Medical Device Manufacturers, Consumers
11/15/16 FDA approves Essure labeling with important safety information for patients and physicians. Consumers, Health Professionals, Medical professionals, Public
10/14/16 Electronic Submission of Labeling for Certain Home-Use Medical Devices Proposed Rule Registered Establishments; Associations; 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

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: 05/25/2017
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