Recently Posted FDA Guidance Documents

9/27/2019 – Clinical Decision Support Software [DRAFT]

The Food and Drug Administration (FDA) has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including software that is intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of diseases or other conditions (often referred to as clinical decision support software). This guidance provides clarity on the scope of FDA’s oversight of clinical decision support software intended for health care professionals, patients, or caregivers.

FDA recognizes that the term “clinical decision support” or “CDS” is used broadly and in different ways, depending on the context. CDS provides health care professionals (HCPs) and patients with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care.1 In the Food and Drug Administration Safety and Innovation Act (FDASIA) Health IT Report of 2014, CDS is described as a variety of tools including, but not limited to: computerized alerts and reminders for providers and patients; clinical guidelines; condition-specific order sets; focused patient data reports and summaries; documentation templates; diagnostic support; and contextually relevant reference information.

The purpose of this guidance is to describe FDA’s regulatory approach to CDS software functions. The agency’s approach includes recent changes to the FD&C Act made by the 21st Century Cures Act (Cures Act), which amended section 520 and excludes certain software functions from the device definition. This guidance clarifies the types of CDS software functions that: (1) do not meet the definition of a device as amended by the Cures Act; (2) may meet the definition of a device but for which, at this time and based on our current understanding of the risks of these devices, FDA does not intend to enforce compliance with applicable device requirements of the FD&C Act, including, but not limited to, premarket clearance and premarket approval requirements; and (3) meet the definition of a device and on which FDA intends to focus its regulatory oversight.


9/27/2019 – General Wellness: Policy for Low Risk Devices

The Food and Drug Administration (FDA) is issuing this guidance document to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health’s (CDRH’s) compliance policy for low risk products that promote a healthy lifestyle (general wellness products). This guidance does not apply to products (e.g., drugs, biologics, dietary supplements, foods, or cosmetics) regulated by other FDA Centers or to combination products.

Section 3060(a) of the 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on December 13, 2016, removing certain software functions, including those intended for maintaining or encouraging a healthy lifestyle that are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition, from the definition of device in section 201(h) of the FD&C Act. Section 520(o)(1)(B) of the FD&C Act, states that software that is intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition” is not a device under section 201(h) of the FD&C Act.

This guidance clarifies FDA’s interpretation of this provision and its application to general wellness products.


9/27/2019 – Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

The Food and Drug Administration (FDA) recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology. The foundation for such inter-communication is hardware and software, typically referred to as medical device data systems (MDDS) that transfer, store, convert formats, and display medical device data or medical imaging data.

On February 15, 2011, the FDA issued a regulation down-classifying MDDS from Class III (high-risk) to Class I (low-risk) (“MDDS regulation”). Since down-classifying MDDS, the FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public. On February 9, 2015, the FDA issued a guidance document to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health… FDA’s current thinking on the definition of MDDS is reflected in this guidance.

More information available here.


9/27/2019 – Off-The-Shelf Software Use in Medical Devices

Off-the-shelf (OTS) Software is commonly being considered for incorporation into medical devices as the use of general-purpose computer hardware becomes more prevalent. The use of OTS Software in a medical device allows the manufacturer to concentrate on the application software needed to run device-specific functions. However, OTS Software intended for general-purpose computing may not be appropriate for a given specific use in a medical device. The medical device manufacturer using OTS Software generally gives up software life cycle control, but still bears the responsibility for the continued safe and effective performance of the medical device.

This guidance document was developed to address the many questions asked by medical device manufacturers regarding what they need to provide in a premarket submission to the FDA when they use OTS Software. The specific response to these questions depends on the medical device in question and the impact on patient, operator, or bystander safety if the OTS Software fails. Thus, the answer to the question, “What do I need to document?” may differ and is based on the risk analysis that is an integral part of designing a medical device. The detail of documentation to be provided to FDA and the level of life cycle control necessary for the medical device manufacturer increase as severity of the hazards to patients, operators, or bystanders from OTS Software failure increases.

This document lays out in broad terms how the medical device manufacturer can consider what is necessary to document for submission to the Agency. A basic set of need-to-document items is recommended for all OTS Software, and a detailed discussion is provided on additional (special) needs and responsibilities of the manufacturer when the severity of the hazards from OTS Software failure become more significant.

For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”


9/27/2019 – Policy for Device Software Functions and Mobile Medical Applications

The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions of software applications (apps) and mobile apps, the rapid pace of innovation, and their potential benefits and risks to public health. The FDA is issuing this guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”) or on general-purpose computing platforms.


9/26/2019 – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act [DRAFT]

This document provides guidance on FDA’s interpretation of the statutory requirement for submission in electronic format; however, this document also contains guidance on additional submission types for which submission in electronic format is anticipated to be recommended. Therefore, to the extent that this guidance describes recommendations that are not “standards,” “timetable,” or “criteria for waivers” and “exemptions” under section 745A(b)(3), this document does not create or confer any rights for or on any person and does not operate to bind FDA or the public, but does represent the Agency’s current thinking on this topic. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff listed on the title page of this guidance.


9/24/2019 – Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations [DRAFT]

The U.S. Food and Drug Administration (FDA or the Agency) values the experience and perspectives of patients and their family caregivers. FDA believes that these individuals can and should be able to provide their insights about a disease or condition, including living with that disease/condition, and the impact of medical devices in the diagnosis, treatment, and management of the disease/condition, through engagement activities. Such activities can assist the Agency in understanding the patient experience, as well as sponsors as they design and conduct medical device clinical investigations.  (“Clinical investigation” is defined in 21 CFR 50.3(c) and 56.102(c).)

This draft guidance is intended to:

  1. help sponsors understand how they can use patient engagement to elicit experience, perspectives, and other relevant information from patient advisors (see definition in Section IV) to improve the design and conduct of medical device clinical investigations;
  2. highlight the benefits of engaging with patient advisors early in the medical device development process;
  3. illustrate which patient engagement activities are generally not considered by FDA to constitute research or an activity subject to FDA’s regulations, including regulations regarding institutional review boards (IRBs); and
  4. address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical investigation.

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