federal_register: 2015-32591
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015-32591 | Electroconvulsive Therapy Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians, and FDA Staff; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians, and FDA Staff." The purpose of this guidance is to make recommendations for 510(k) submissions and complying with special controls being proposed to support reclassification of ECT Devices into Class II (special controls) for severe major depressive episode (MDE) associated with Major Depressive Disorder (MDD) or Bipolar Disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. This draft guidance is not final nor is it in effect at this time. | 2015-12-29 | 2015 | 12 | https://www.federalregister.gov/documents/2015/12/29/2015-32591/electroconvulsive-therapy-devices-for-class-ii-intended-uses-draft-guidance-for-industry-clinicians | https://www.govinfo.gov/content/pkg/FR-2015-12-29/pdf/2015-32591.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses: Draft Guidance for Industry, Clinicians, and FDA Staff." The purpose of this... |