Medical Devices

Letters to Industry

This webpage is a resource for external stakeholders that contain correspondence issued by the Center for Devices and Radiological Health (CDRH) for a variety of purposes. These primarily include Warning Letters, Untitled Letters, "It Has Come To Our Attention" letters and letters used to communicate broadly with industry.

Chapter 4 of the Regulatory Procedures Manual (RPM) contains Agency guidance and procedures for Warning Letters and Untitled Letters.

Warning Letters

Chapter 4-1-1 of the RPM, on Warning Letter Procedures states “When it is consistent with the public protection responsibilities of the agency and depending on the nature of the violation, it is the Food and Drug Administration’s (FDA) practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. Warning Letters are issued to achieve voluntary compliance and to establish prior notice. (Prior notice is discussed in Chapter 10 of the Regulatory Procedures Manual. The use of Warning Letters and the prior notice policy are based on the expectation that most individuals and firms will voluntarily comply with the law.

The agency position is that Warning Letters are issued only for violations of regulatory significance. Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency’s principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (the Act).”

Consistent with Chapter 4-1-13 of the RPM on Freedom of Information, all FDA-issued Warning Letters (redacted) should be posted on FDA.gov to permit the public to obtain a copy directly without the need to submit a formal FOIA request.

Untitled Letters

Chapter 4-2-1 of the RPM, Untitled Letters Policy states “An Untitled Letter cites violations that do not meet the threshold of regulatory significance for a Warning Letter.” Unlike a Warning Letter, an Untitled Letter does not include a statement that warns the individual or firm that failure to promptly correct the violation may result in enforcement action.

Consistent with Agency practice described on the Issuance of Untitled Letters webpage, webpage, FDA generally posts an Untitled Letter to a Center website on FDA.gov when the Center has determined posting would be appropriate because one or more of the following apply: (1) FDA has received or anticipates receiving 3 or more requests for the letter under the Freedom of Information Act (FOIA); (2) FDA believes that doing so would inform the public about violative practices and conditions that may pose a risk to their health; (3) FDA believes that doing so would deter future violations and allow similarly situated regulated entities to determine what activities and practices FDA finds violative and use the information to increase compliance with the law. This policy does not preclude Center offices from electing to proactively post all untitled letters within a particular program area. Where FDA adopts an approach to posting untitled letters in a particular program area, the posting will be done as soon as possible, but normally no later than 10 workdays after the letter has been issued.

It Has Come to Our Attention Letters (IHCTOA)

In certain situations, CDRH may become aware that regulated industry may be promoting a medical device product in a manner that potentially violates the Federal Food, Drug, and Cosmetic Act and its implementing regulations. CDRH may issue an “It Has Come to Our Attention” Letter (IHCTOA Letter) to regulated industry as an early communication to gather additional information and provide the member of regulated industry. Certain IHCTOA letters were publicly posted prior to the update of this website, and remain available here. These letters are not intended to communicate that FDA is considering enforcement action and therefore will not be publicly posted in the future, but remain subject to disclosure pursuant to FOIA.

Communication Letters

CDRH also issues letters to industry, which are intended to serve as communication products that inform industry broadly of issues related to specific devices or a class of devices. CDRH generally posts these letters to ensure widest distribution of messaging.

Letters to Industry (Medical Devices)

TitleCategoryDate
UDI Extension Letter to Rigid Gas Permeable Contact Lens Manufacturers - September 22, 2016 (PDF - 128KB) Communication 09/22/16
UDI Extension Letter to Device Labelers - September 6, 2016 (PDF - 163KB) Communication 10/06/16
Syringe Pump Labeling Request Letter (PDF - 69KB) Communication 08/24/16
Letter to Endometrial Ablation Industry about Objective Performance Criteria (PDF - 97KB) Communication 10/29/15
DuPont Letter Regarding Transition Tyvek (PDF - 199KB) Communication 10/02/15
Pathway Genomics Letter - September 21, 2015 (PDF - 48KB) IHCTOA 09/21/15
Fujifilm Corp 510k Status Letter - August 12, 2015 (PDF - 604KB) IHCTOA 08/12/15
Hoya (Pentax) Corp 510k Status Letter - August 12, 2015 (PDF - 449KB) IHCTOA 08/12/15
Soft Tissue Fillers Labeling Request Letter (PDF - 38KB) Communication 05/26/16
Olympus Medical Systems It Has Come To Our Attention Letter - March 18, 2014 (PDF - 391KB) IHCTOA 03/18/14
UDI Extension Letter to Class III Contact Lens and Intraocular Lens Labelers - August 15, 2014 Communication 08/19/14
UDI Extension Letter to Implant Labelers - November 19, 2014 (PDF - 119KB) Communication 11/19/15
Letter Regarding Removal of Notary Block on Export Certificates Communication 03/01/14
Letter to Medical Device Establishments: Enhancements to CDRH Export Certification and Tracking System (CECATS) (PDF - 86KB) Communication 02/24/14
Letter to Biosense Technologies Private Limited concerning the uChek Urine Analyzer IHCTOA 05/21/13
Letter to Manufacturers Concerning SIDS Prevention Medical Claims for Baby Products Communication 10/17/11
Letter To Foreign and Domestic Medical Device and Component Establishments That May Be Affected by the March 2011 Japan Earthquake and Tsunami Communication 06/01/11
Letter to Manufacturers of External Defibrillators About Developing Safer Products Communication 11/15/10
Letter to Manufacturers Concerning Medical Claims About Infant Sleep Positioners: Devices Can Create Risk of Suffocation Communication 09/29/10
Letter to Manufacturers of 510(k)-cleared Infant Positioners: Devices Can Create Risk of Suffocation Communication 09/29/10
Manufacturers of Lancets: Potential for Transmitting Blood-borne Infections with Multiple-use Lancing (Finger Stick) Devices and Requested Actions (PDF) (PDF - 36KB) Communication 09/20/10
Letter to Electric Dental Handpiece Manufacturers Regarding Reports of Overheating and Patient Burns Communication 08/20/10
Letter to Electric Oral Bone Cutting Handpiece Manufacturers Regarding Reports of Overheating and Patient Burns Communication 08/20/10
Letter to Manufacturers of Enteral Feeding Tubes (PDF - 27KB) Communication 07/09/10
Letter to Infusion Pump Manufacturers Communication 04/23/10
Medical Claims on Labeling and Promotional Materials of Infant Mattresses and Infant Positioners Distributed in the United States (PDF Version) (PDF - 11KB) Communication 03/13/00
CDRH Clarifies Classification of EEG Devices Communication 08/21/12

Letters to Industry (Radiological Health)

TitleCategoryDate
Letter to the Medical Imaging Technology Alliance Regarding Fluoroscopic X-ray Systems (PDF - 268KB) Communication 04/17/14
Letter to the Medical Imaging Technology Alliance Regarding Certified X-ray Components and Systems (PDF - 188KB) Communication 01/30/14
Letter to the Indoor Tanning Association on Red Lamps for Skin Rejuvenation Being Installed in Tanning Beds/Booths Communication 12/21/11
Memo to the Conference of Radiation Control Program Directors on Red Lamps for Skin Rejuvenation Being Installed in Tanning Beds/Booths Communication 12/21/11

Letters to Industry (In Vitro Diagnostics)

TitleCategoryDate
Letter to Viracor-IBT Laboratories, Inc. regarding Zika Virus IgG, and Zika Virus IgG and IgM Panel (PDF - 921KB) Untitled 10/21/16
Letter to Medical Diagnostic Laboratories, LLC regarding the Zika Virus–Blood–PCR Test (PDF - 40KB) IHCTOA 03/23/16
Letter to First Diagnostic Corporation regarding the ATFirst’s One Step Zika Antibody Test (PDF - 691KB) IHCTOA 03/10/16
Letter to Texas Children’s Hospital and Houston Methodist Hospital regarding the Zika Direct Test (PDF - 558KB) IHCTOA 03/10/16
Letter to MD Biosciences Regarding the Zika Virus RNA by RT-PCR Assay (PDF - 357KB) IHCTOA 03/04/16
Letter to SoloPAP concerning the SoloPAP Home HPV&PAP test (PDF - 202KB) IHCTOA 02/17/16
Letter to Sure Genomics, Inc. concerning SureDNA Test for Collection of Saliva Samples for DNA Sequencing (PDF - 122KB) IHCTOA 02/16/16
Letter to Healthspek LLC concerning the Healthspek PGT test for genes affecting drug metabolism (PDF - 161KB) IHCTOA 12/07/15
Letter to Genomic Express, Inc. concerning pharmacogenomic tests (PDF - 185KB) IHCTOA 12/07/15
Letter to Kailos Genetics, Inc. concerning test to analyze multiples genes (PDF - 176KB) IHCTOA 11/16/15
Letter to Harmonyx concerning test for antiplatelets, statins, ADHD, and pain (PDF - 174KB) IHCTOA 11/16/15
Letter to Knome, Inc. Concering the KnomeCOMPLETE (PDF - 91KB) IHCTOA 06/10/10
Letter to 23andMe, Inc. Concerning the 23andMe Personal Genome Service (PDF - 163KB) IHCTOA 06/10/10
Letter to deCODE Genetics Concerning the deCODEme Complete Scan (PDF - 192KB) IHCTOA 06/10/10
Letter to Illumina, Inc. Concerning the Illumina Infinium HumanHap550 array (PDF - 169KB) IHCTOA 06/10/10
Letter to Navigenics Concerning the NaviGenics Health Compass (PDF - 114KB) IHCTOA 06/10/10
Letter to Pathway Genomics Corporation Concerning the Pathway Genomics Genetic Health Report (PDF Version) (PDF - 223KB) IHCTOA 05/10/10
Letter to Manufacturers of Troponin Assays Listed with the FDA Communication 10/16/10
Letter to Manufacturers of Blood Glucose Monitoring Systems Listed With the FDA Communication 09/16/10
Letters to Manufacturers Concerning Genetic Tests IHCTOA 07/19/10
Letter to Manufacturers With HbA1c Assays Listed With the FDA Communication 07/06/10
Letter to DNA-Cardiocheck, Inc. Concerning the DNA CardioCheck Test (PDF - 167KB) IHCTOA 11/02/15
Letter to DNA4Life Concerning the Pharmacogenetic Report (PDF - 164KB) IHCTOA 11/02/15
Letter to Interleukin Genetics, Inc. Concerning the PerioPredict® Genetic Test (PDF - 211KB) IHCTOA 11/04/15

Page Last Updated: 03/16/2017
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