1. Standards for medical devices: Electroconvulsive therapy machine.
- Author
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Gangadhar BN, Sreeraj VS, Sinha P, and Thirthalli J
- Subjects
- United States, Humans, United States Food and Drug Administration, India, Electroconvulsive Therapy
- Abstract
The manuscript calls for establishing a standard for electroconvulsive devices by manufacturers for better regulation in India. This is most relevant in the context of two recent developments, (a) Notification of medical devices rules, 2017 with classification of ECT as Class C and (b) Recent change in classification of ECT devices by US-FDA in 2018. The establishment of standards would help in upregulating the standard of ECT devices as well as ECT practices., Competing Interests: Declaration of Competing Interest Authors declare no conflict of interest and no relevant financial disclosures., (Copyright © 2024 Elsevier B.V. All rights reserved.)
- Published
- 2024
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