Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is issuing a final order to reclassify the electroconvulsive therapy (ECT) device for use in treating catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, which is a preamendments class III device, into class II (special controls). FDA is also issuing this final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the preamendments class III ECT devices for all other uses that are not being reclassified to class II (product code GXC).
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 882 [Docket No. FDA-2014-N-1210] AGENCY: Food and Drug Administration, HHS. ACTION: Final order. SUMMARY: The Food and Drug Administration (FDA) is issuing a final order to reclassify the electroconvulsive therapy (ECT) device for use in treating catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, which is a preamendments class III device, into class II (special controls). FDA is also issuing this final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the preamendments class III ECT devices for all other uses that are not being reclassified to class II (product code GXC). DATES: This order is effective on December 26, 2018. See further discussion in section V, Implementation Strategy. FOR FURTHER INFORMATION CONTACT: Carlos Peña, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2680, Silver Spring, MD 20993, 301-796-6610, carlos.pena@fda.hhs.gov . SUPPLEMENTARY INFORMATION: Table of Contents I. Table of Abbreviations/Commonly Used Acronyms in This Document II. Background A. Reclassification B. Requirement fo…
Other Federal Register documents from the same docket.
Citation: 83 FR 66103
