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:

Date	Subject	Audience
05/20/13	Updated FDA Website on Medical X-ray Imaging and Fluoroscopy	Radiological Associations; Societies; Consumer Groups
05/17/13	FDA Issues Guidance on the CDRH Appeals Process	Registered Firms; Associations
04/19/13	FDA Proposed Rule; Use of Symbols for Medical Labeling	Associations; Organizations; International Organizations
04/11/13	FDA Issues Guidance on Medical Device Classification Product Codes	Associations
04/04/13	Letter to Industry, Brokers, and Importers regarding New Product Codes for Investigational Use Only In Vitro Diagnostic Devices	Registered Establishments
04/01/13	FDA Issues Two Final Guidance Documents on User Fees and Refunds for 510(k)s and PMAs	Registered Establishments
03/05/13	FDA Issues Draft Guidance: Types of Communication during the Review of the Medical Device Submissions	Registered Establishments; Device Associations
02/26/13	Weather Effects on Medical Device Safety and Quality; Federal Register Notice; Request for Comments	Associations
02/19/13	FDA Draft Guidance; Providing Information about Pediatric Uses of Medical Devices	Registered Firms; Associations
02/11/13	Cardiovascular Devices 30 Day Notice Submission Reviews	Cardiovascular Device Registered Establishment
12/31/12	FDA Final Guidance on Acceptance and Filing Criteria for 510(k)s and PMAs	Registered Establishments; Associations
12/31/12	FDA Issues Final Guidance on eCopy Program	Registered Establishments; Associations
12/17/12	Information about FDA/CDRH Reorganization	Associations; Radiation Organizations; Government Agencies
12/14/12	New CDRH Learn Module: MDUFMA III Overview	Associations
12/12/12	Home Use Initiative	Associations; Consumer Groups
12/05/12	Annual Medical Device Establishment Registration Extended	Registered Establishments; Device Associations
11/29/12	CDRH Export Certification and Tracking System (CECATS) Launch	Registered Establishments; Associations
11/29/12	Letter to Industry Announcing the Launch of the CDRH Export Certification and Tracking System (CECATS)	Medical Device Establishments
08/20/12	Medical Device User Fees for FY 2013	ALL Registered Establishments; Associations

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