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.
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.
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.
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.