federal_register: E8-2325

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
E8-2325 Devices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data System Proposed Rule The Food and Drug Administration (FDA) is proposing to reclassify, on its own initiative, the Medical Device Data System (MDDS) from class III (premarket approval) to class I (general controls). This action does not include medical device data systems with new diagnostic or alarm functions. FDA is also proposing that the MDDS be exempt from the premarket notification requirements when it is indicated for use only by a healthcare professional and does not perform irreversible data compression. 2008-02-08 2008 2 https://www.federalregister.gov/documents/2008/02/08/E8-2325/devices-general-hospital-and-personal-use-devices-reclassification-of-medical-device-data-system https://www.govinfo.gov/content/pkg/FR-2008-02-08/pdf/E8-2325.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to reclassify, on its own initiative, the Medical Device Data System (MDDS) from class III (premarket approval) to class I (general controls). This action does not include medical device data systems...  

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