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# Comments on Increasing Home Medical Tech Use
- URL: https://www.fdaweb.com/comments-on-increasing-home-medical-tech-use/
- Published: 2023-08-30T12:00:00.000Z
- Updated: 2026-09-14T18:53:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155214

Responding to an FDA call for public input, the American College of Cardiology [says](https://www.regulations.gov/comment/FDA-2023-N-1956-0063?ref=fdaweb.com) digital health is “transforming the practice of medicine. The demand and development of medical technologies for at-home use by patients has grown exponentially and has the potential to provide great opportunities to improve outcomes, drive down costs, and increase access to innovative and lifesaving solutions.” Its submission includes detailed answers to FDA’s questions. The group says that despite its endorsement of several areas for exploration, “it is important to note that many challenges remain to successful implementation of at-home medical technologies. The deployment of new tools comes with risks that could put patients in harm’s way and threaten the clinician-patient relationship that has been the central tenant of medicine. As FDA and other federal agencies begin to examine ways to expand access to these at-home use technologies, it is essential that any regulations reaffirm that the clinician, not the system/technology, is ultimately at the core of providing care to the patients.”

B. Braun says technologies exist that could enable bi-directional communication to devices and by patients in the at-home environment that are both private and secure and don’t require a unique and intrusive set-up. The company [recommends](https://www.regulations.gov/comment/FDA-2023-N-1956-0069?ref=fdaweb.com) that the agency consider collaborating with manufacturers toward clearance of such technologies for use in medical devices such as infusion pumps used in the home.

In its [comment](https://www.regulations.gov/comment/FDA-2023-N-1956-0066?ref=fdaweb.com), Otsuka acknowledges FDA’s effort to provide recommendations to industry on the topic and responds to specific questions the agency asked in the FDA docket.

The Medical Device Manufacturers Association [gives](https://www.regulations.gov/comment/FDA-2023-N-1956-0077?ref=fdaweb.com) specific answers to FDA’s detailed questions.

Finally, Abbott [says](https://www.regulations.gov/comment/FDA-2023-N-1956-0072?ref=fdaweb.com) often overlooked in a discussion of healthcare accessibility are diagnostic tests for laboratories certified as waived under the Clinical Laboratories Improvement Act. The company says its responses to FDA’s questions include diagnostic tests in waived laboratories, even when the questions reference a non-clinical setting.