2019-21001. Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act; Guidance for Industry and Food and Drug Administration Staff; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act.” This guidance provides clarity on FDA's current thinking regarding changes made by the 21st Century Cures Act (Cures Act) to the definition of a medical device and the resulting effect on guidances related to medical device software.

DATES:

The announcement of the guidance is published in the Federal Register on September 27, 2019.

ADDRESSES:

You may submit either electronic or written comments on Agency guidances at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2017-D-6294 for “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act; Guidance for Industry and Food and Drug Administration Staff.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT:

Bakul Patel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5458, Silver Spring, MD 20993-0002, 301-796-5528; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

FDA has long regulated software that meets the definition of a device. Section 3060(a) of the Cures Act, enacted on December 13, 2016 (Pub. L. 114-255), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to exclude certain software functions from the definition of device under section 201(h) of the FD&C Act (21 U.S.C. 321(h)). The software functions that are removed from the definition of device are described in section 520(o)(1) of the FD&C Act (21 U.S.C. 360j(o)(1)), and the intended uses of such software functions can be summarized as follows: (1) For administrative support of a healthcare facility, (2) for maintaining or encouraging a healthy lifestyle, (3) to serve as electronic patient records, (4) for transferring, storing, converting formats, or displaying data, or (5) providing certain types of clinical decision support to a healthcare provider unless interpreting or analyzing a clinical test or other device data.

This guidance provides FDA's current thinking regarding the amended device definition and the resulting effect the amended definition has on published FDA guidance, including the policies expressed in guidance about mobile medical applications; medical device data systems used for the electronic transfer, storage, display, or conversion of medical device data; medical image storage devices, used to store or retrieve medical images electronically; and general wellness products. This guidance focuses on the first four categories of software functions that are excluded from the device definition. FDA will address the fifth category in a separate guidance. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance entitled “Clinical Decision Support Software” to provide clarification of its interpretation of section 520(o)(1)(E) of the FD&C Act, which describes certain software functions intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of disease or other conditions. Section 520(o)(2) of the FD&C Act describes the regulation of a product with multiple functions, including at least one device function and at least one software function that is not a device. FDA intends to provide recommendations on the regulation of such products with multifunctionality in a separate guidance document.

FDA considered comments received on the draft guidance that appeared in the Federal Register of December 8, 2017 (82 FR 57991). FDA revised the guidance as appropriate in response to the comments. FDA has provided additional clarity that hardware intended to transfer, store, convert formats, and display medical device data and results remain devices, while software functions intended to transfer, store, convert formats, or display data are no longer devices if they meet the definition in 520(o)(1)(D) of the FD&C Act. The examples included in the draft of this guidance that described alarms, alerts, or flags have been removed from this guidance, because they are not excluded from the definition of device under section 520(o)(1)(D) of the FD&C Act in that these functions involve analysis or interpretation of laboratory test or other device data and results. These functions are addressed in section 520(o)(1)(E) of the FD&C Act, the regulation of which will be described in the separate “Clinical Decision Support Software” guidance document.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

III. Electronic Access

Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/​medical-devices/​device-advice-comprehensive-regulatory-assistance/​guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov or https://www.fda.gov/​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act” may send an email request to [e-mail] to receive an electronic copy of the document. Please use the document number 17030 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the following FDA regulations have been approved by OMB as listed in the following table:

21 CFR part	Topic	OMB Control No.
807, subparts A through D	Establishment Registration And Device Listing	0910-0625
807, subpart E	Premarket Notification	0910-0120
800, 801, and 809	Medical Device Labeling Regulations	0910-0485
803	Medical Devices; Medical Device Reporting; Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor Reporting	0910-0437
820	Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation	0910-0073

Dated: September 23, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.