federal_register: 2010-7637

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2010-7637 Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II Devices and Exemption From Premarket Notification Proposed Rule The Food and Drug Administration (FDA) is proposing to amend certain neurological device and physical medicine device regulations to establish special controls for these class II devices and to exempt some of these devices from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of draft guidance documents that would serve as special controls for each of these devices if the rule is finalized. 2010-04-05 2010 4 https://www.federalregister.gov/documents/2010/04/05/2010-7637/neurological-and-physical-medicine-devices-designation-of-special-controls-for-certain-class-ii https://www.govinfo.gov/content/pkg/FR-2010-04-05/pdf/2010-7637.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to amend certain neurological device and physical medicine device regulations to establish special controls for these class II devices and to exempt some of these devices from the premarket...

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