{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is classifying the pediatric Autism Spectrum Disorder (ASD) diagnosis aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the pediatric Autism Spectrum Disorder diagnosis aid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.","action":"Final amendment; final order.","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/2022/12/30/2022-28430.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"882","title":21}],"citation":"87 FR 80444","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective December 30, 2022. The classification was applicable on June 2, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-N-3188"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2022-12-30","updated_at":"2023-02-27T20:58:41.723-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-3188-0001","allow_late_comments":null,"id":"FDA-2022-N-3188-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-N-3188","title":"Medical Devices; Neurological Devices; Classification of the Pediatric Autism Spectrum Disorder Diagnosis Aid"}],"document_number":"2022-28430","effective_on":"2022-12-30","end_page":80446,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/12/30/2022-28430.xml","html_url":"https://www.federalregister.gov/documents/2022/12/30/2022-28430/medical-devices-neurological-devices-classification-of-the-pediatric-autism-spectrum-disorder","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-28430?publication_date=2022-12-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-12-30/2022-28430/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2007,"last_updated":"2026-07-26 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-12-30/pdf/2022-28430.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-28430.pdf?1672321519","publication_date":"2022-12-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/12/30/2022-28430.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2022-N-3188","supporting_documents_count":0,"docket_id":"FDA-2022-N-3188","document_id":"FDA-2022-N-3188-0001","regulation_id_number":null,"title":"Medical Devices; Neurological Devices; Classification of the Pediatric Autism Spectrum Disorder Diagnosis Aid","checked_regulationsdotgov_at":"2023-02-28T01:58:40Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":80444,"subtype":null,"title":"Medical Devices; Neurological Devices; Classification of the Pediatric Autism Spectrum Disorder Diagnosis Aid","toc_doc":"Neurological Devices; Classification of the Pediatric Autism Spectrum Disorder Diagnosis Aid","toc_subject":"Medical Devices:\n","topics":["Medical devices"],"type":"Rule","volume":87}