federal_register: 2015-01619

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2015-01619 Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems Rule The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use). 2015-01-29 2015 1 https://www.federalregister.gov/documents/2015/01/29/2015-01619/effective-date-of-requirement-for-premarket-approval-for-automated-external-defibrillator-systems https://www.govinfo.gov/content/pkg/FR-2015-01-29/pdf/2015-01619.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary...

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