FDA Interoperability Designation—Creating Options for People With Diabetes and Pump Companies: Regulatory, Technological, and Commercial Perspectives-Reference-Cited by-同舟云学术

FDA Interoperability Designation—Creating Options for People With Diabetes and Pump Companies: Regulatory, Technological, and Commercial Perspectives

Published:2024-09-10 Issue: Volume: Page:
ISSN:1932-2968
Container-title:Journal of Diabetes Science and Technology
language:en
Short-container-title:J Diabetes Sci Technol

Author:

Klonoff David C.¹²^ORCID,Ho Cindy N.²^ORCID,Ayers Alessandra²^ORCID,Abdel-Malek Aiman³⁴^ORCID

Affiliation:

1. Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA

2. Diabetes Technology Society, Burlingame, CA, USA

3. Thirdwayv Inc., Irvine, CA, USA

4. Apex Medical Ai Inc., Irvine, CA, USA

Publisher

SAGE Publications

Link

https://journals.sagepub.com/doi/pdf/10.1177/19322968241271304

Reference36 articles.

1. Food and Drug Administration. FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system. https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-interoperable-automated-insulin-dosing-controller-designed-allow-more-choices. Published March 24, 2020. Accessed July 15, 2024.

2. Kelm K. Re: SmartAdjust Technology 510(k) Premarket Notification of Intent to Market the Device. US FDA; 2022. www.accessdata.fda.gov/cdrh_docs/pdf20/K203774.pdf. Accessed July 15, 2024.

3. Insulet Announces FDA 510(k) Clearance of the Omnipod® 5 App for iPhone. https://investors.insulet.com/news/news-details/2023/Insulet-Announces-FDA-510k-Clearance-of-the-Omnipod-5-App-for-iPhone/default.aspx. Accessed July 15, 2024.

4. Federal Register. Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Interoperable Automated Glycemic Controller. https://www.federalregister.gov/documents/2022/03/14/2022-05303/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the. Published March 14, 2022. Accessed July 15, 2024.

5. Food and Drug Administration. FDA Roundup: January 24, 2023.https://www.fda.gov/news-events/press-announcements/fda-roundup-january-24-2023. Published January 24, 2023. Accessed July 15, 2024.