Letters to Industry
NOTE: An Untitled Letter is an initial correspondence with regulated industry that cites violations that do not meet the threshold of regulatory significance for a Warning Letter. CDRH issues advertising and promotion Untitled Letters to companies that commercially distribute medical devices. As part of the Transparency Initiative, CDRH has committed to posting its advertising and promotion Untitled Letters from October 1, 2011.
Letters to Industry (Medical Devices)
Letter Regarding Removal of Notary Block on Export Certificates Letter to Medical Device Establishments: Enhancements to CDRH Export Certification and Tracking System (CECATS)(PDF - 86KB) Letter to Biosense Technologies Private Limited concerning the uChek Urine Analyzer Important Information on the Medical Device User Fee Rates for FY 2013[ARCHIVED] Medical Device Establishment Registration and Listing - Notice of Changes for FY 2013 Letter to Manufacturers Concerning SIDS Prevention Medical Claims for Baby Products Letter To Foreign and Domestic Medical Device and Component Establishments That May Be Affected by the March 2011 Japan Earthquake and Tsunami Letter to Industry about Import Entry Review Process (March 24, 2011) Letter to Manufacturers of External Defibrillators About Developing Safer Products Letter to Manufacturers Concerning Medical Claims About Infant Sleep Positioners: Devices Can Create Risk of Suffocation Letter to Manufacturers of 510(k)-cleared Infant Positioners: Devices Can Create Risk of Suffocation Manufacturers of Lancets: Potential for Transmitting Blood-borne Infections with Multiple-use Lancing (Finger Stick) Devices and Requested Actions Letter to Electric Dental Handpiece Manufacturers Regarding Reports of Overheating and Patient Burns Letter to Electric Oral Bone Cutting Handpiece Manufacturers Regarding Reports of Overheating and Patient Burns Letter to Manufacturers of Enteral Feeding Tubes(PDF - 27KB) Letter to Infusion Pump Manufacturers Medical Claims on Labeling and Promotional Materials of Infant Mattresses and Infant Positioners Distributed in the United States Archived Letters to Industry 2012
Letters to Industry (Radiological Health)
Letter to the Medical Imaging Technology Alliance Regarding Fluoroscopic X-ray Systems(PDF - 268KB) Letter to the Medical Imaging Technology Alliance Regarding Certified X-ray Components and Systems(PDF - 188KB) Letter to the Indoor Tanning Association on Red Lamps for Skin Rejuvenation Being Installed in Tanning Beds/Booths Memo to the Conference of Radiation Control Program Directors on Red Lamps for Skin Rejuvenation Being Installed in Tanning Beds/Booths Letter to Industry about Import Entry Review Process (September 6, 2011)
Letters to Industry (In Vitro Diagnostics)
Letter to Knome, Inc. Concering the KnomeCOMPLETE(PDF - 91KB) Letter to 23andMe, Inc. Concerning the 23andMe Personal Genome Service(PDF - 163KB) Letter to deCODE Genetics Concerning the deCODEme Complete Scan(PDF - 192KB) Letter to Illumina, Inc. Concerning the Illumina Infinium HumanHap550 array(PDF - 169KB) Letter to Navigenics Concerning the NaviGenics Health Compass(PDF - 114KB) Letter to Pathway Genomics Corporation Concerning the Pathway Genomics Genetic Health Report Letter to Manufacturers of Troponin Assays Listed with the FDA Letter to Manufacturers of Blood Glucose Monitoring Systems Listed With the FDA Letters to Manufacturers Concerning Genetic Tests Letter to Manufacturers With HbA1c Assays Listed With the FDA