Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

You should submit comments and suggestions regarding this draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov.  Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions about this document regarding CDRH-regulated devices, contact Bakul Patel at 301-796-5528, or email at [email protected] or contact the Office of the Center Director at 301-796-5900.

Preface

Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to [email protected] to receive a copy of the guidance.  Please use the document number 1400021 to identify the guidance you are requesting.

Table of Contents

1. Introduction
2. Background
3. Policy for Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
4. Edits to 2013 Mobile Medical Applications Guidance

This draft guidance when finalized will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. 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 responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

1 Class I devices are subject to general controls under the Federal Food, Drug, and Cosmetic Act (FDC Act).  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. Therefore, the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS devices, medical image storage devices, and medical image communications devices.

This document is also proposing edits to the Agency’s guidance entitled “Mobile Medical Applications” (September 25, 2013) which would conform to the policy discussed in this draft guidance, when finalized.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

medical device ² intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices:

• The electronic transfer or exchange of medical device data. For example, this would include software that collects output from a ventilator about a patient’s CO2 level and transmits the information to a central patient data repository.
• The electronic storage and retrieval of medical device data. For example, software that stores historical blood pressure information for later review by a healthcare provider.
• The electronic conversion of medical device data from one format to another in accordance with a preset specification. For example, software that converts digital data generated by a pulse oximeter into a digital format that can be printed.
• The electronic display of medical device data. For example, software that displays a previously stored electrocardiogram for a particular patient.

MDDS may include the following, provided the intended use is consistent with the MDDS regulation:

• Any assemblage or arrangement of network components that includes specialized software or hardware expressly created for a purpose consistent with the intended use in the MDDS regulation;
• Products specifically labeled (per 21 CFR 801) by the manufacturer as an MDDS, provided such products do not provide additional functionality.
• Custom software that is written by entities other than the original medical device manufacturer (for example, hospitals, third party vendors) that directly connects to a medical device, to obtain medical device information.
• Modified portions of software or hardware that are part of an IT infrastructure created and/or modified (writing and compiling software) for specific MDDS functionality. For example, when modifying software for MDDS functionality, only the modified portion is considered MDDS; the original software is not.

A medical image storage device, defined under 21 CFR 892.2010, is a device that provides electronic storage and retrieval functions for medical images.

A medical image communications device, defined under 21 CFR 892.2020, is a device that provides electronic transfer of medical image data between medical devices.

Device Advice: Is The Product A Medical Device?