2021-27825. Technical Considerations for Medical Devices With Physiologic Closed-Loop Control Technology; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology.” Physiologic Closed-Loop Control (PCLC) devices are intended for automatic control of a physiologic variable(s) through delivery of energy or substance using feedback from physiologic sensors. PCLC devices may play an important role in reducing cognitive overload, minimizing human error, and enhancing medical care during emergency response and medical surge situations. This draft guidance provides technical considerations for PCLC technology in order to promote development and availability of safe and effective PCLC medical devices. This draft guidance is not final nor is it in effect at this time.

DATES:

Submit either electronic or written comments on the draft guidance by February 22, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

ADDRESSES:

You may submit comments on any guidance 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-2021-D-0996 for “Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology.” 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, 240-402-7500.

• 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.govinfo.gov/​content/​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, 240-402-7500.

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 draft guidance document entitled “Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology” to the Office of Policy, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT:

Christopher Scully, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 1129, Silver Spring, MD 20993-0002, 301-796-2928.

SUPPLEMENTARY INFORMATION:

I. Background

PCLC technology can enable automation in a variety of medical device types including infusion systems, ventilators, extracorporeal systems, and stimulation systems. Automated adjustments of a physiologic variable(s) through the delivery of energy or substance ( i.e., therapy), such as automated fluid resuscitation, ventilation/oxygenation, and anesthesia delivery, are emerging applications for the critical and emergency care environments. PCLC devices may benefit the patient by facilitating safe and effective, consistent, and timely delivery of appropriate therapy with improved and distraction-free performance. However, introducing automation and reducing clinician involvement can incur new types of hazards which may render the medical device unsafe if not properly designed or evaluated. This guidance provides technical considerations for PCLC technology during device development to support the safe and effective design and evaluation of PCLC medical devices.

CDRH held a public workshop entitled “Physiological Closed-Loop Controlled Devices” on October 13 and 14, 2015,^[1] with the aim of fostering an open discussion on design and evaluation considerations associated with PCLC devices used in critical care environments. This workshop provided a forum for medical device manufacturers, clinical users, and academia to discuss technical considerations for automated medical devices with PCLC technology. The feedback and recommendations provided at the meeting were incorporated in this draft guidance.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology. 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.

II. Electronic Access

Persons interested in obtaining a copy of the draft 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/​regulatory-information/​search-fda-guidance-documents. Persons unable to download an electronic copy of “Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology” may send an email request to [e-mail] to receive an electronic copy of the document. Please use the document number 1500085 and complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations, guidance, and forms have been approved by OMB as listed in the following table:

21 CFR part; guidance; or FDA form	Topic	OMB Control No.
807, subpart E	Premarket notification	0910-0120
814, subparts A through E	Premarket approval	0910-0231
814, subpart H	Humanitarian Device Exemption	0910-0332
812	Investigational Device Exemption	0910-0078
“De Novo Classification Process (Evaluation of Automatic Class III Designation)”	De Novo classification process	0910-0844
“Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff”	Q-submissions	0910-0756
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
58	Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies	0910-0119

Dated: December 17, 2021.

Lauren K. Roth,

Associate Commissioner for Policy.

Footnotes

1.  See http://wayback.archive-it.org/​7993/​20170112084803/​http:/www.fda.gov/​MedicalDevices/​NewsEvents/​WorkshopsConferences/​ucm457581.htm.