{"abstract":"The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the Cranial Electrotherapy Stimulator. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the device. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of the cranial electrotherapy stimulator based on new information. This action implements certain statutory requirements.","action":"Proposed rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2011/08/08/2011-19957.html","cfr_references":[{"chapter":null,"citation_url":null,"part":882,"title":21}],"citation":"76 FR 48062","comment_url":null,"comments_close_on":"2011-11-07","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments by November 7, 2011. Submit requests for a change in classification by August 23, 2011. FDA intends that, if a final rule based on this proposed rule is issued, anyone who wishes to continue to market the device will need to submit a PMA within 90 days of the effective date of the final rule. Please see section XII of this document for the effective date of any final rule that may publish based on this proposal.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-N-0504"],"dockets":[],"document_number":"2011-19957","effective_on":null,"end_page":48070,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/08/08/2011-19957.xml","html_url":"https://www.federalregister.gov/documents/2011/08/08/2011-19957/effective-date-of-requirement-for-premarket-approval-for-cranial-electrotherapy-stimulator","images":{"EP08AU11.171":{"original_size":"https://img.federalregister.gov/EP08AU11.171/EP08AU11.171_original_size.gif"},"EP08AU11.172":{"original_size":"https://img.federalregister.gov/EP08AU11.172/EP08AU11.172_original_size.gif"}},"images_metadata":{"EP08AU11.171":{"original_size":{"identifier":"EP08AU11.171","content_type":"image/gif","size":151381,"width":3707,"sha":"0ce9f7a569cfc9582d11ab7b63612623","url":"https://img.federalregister.gov/EP08AU11.171/EP08AU11.171_original_size.gif","height":2310}},"EP08AU11.172":{"original_size":{"identifier":"EP08AU11.172","content_type":"image/gif","size":58491,"width":3242,"sha":"1910a36f2e5cfd522d9caede8400fc0f","url":"https://img.federalregister.gov/EP08AU11.172/EP08AU11.172_original_size.gif","height":2273}}},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-19957?publication_date=2011-08-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-08-08/2011-19957/mods.xml","not_received_for_publication":null,"page_length":9,"page_views":{"count":1406,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-08-08/pdf/2011-19957.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2011-08-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/08/08/2011-19957.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-N-0504","supporting_documents_count":0,"docket_id":"FDA-2011-N-0504","regulation_id_number":null,"title":"Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator; Closed","checked_regulationsdotgov_at":"2011-08-27T08:04:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":48062,"subtype":null,"title":"Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator","toc_doc":"Requirement for Premarket Approval for Cranial Electrotherapy Stimulator","toc_subject":null,"topics":["Medical devices"],"type":"Proposed Rule","volume":76}