federal_register: 2016-04579

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2016-04579 Effective Date of Requirement for Premarket Approval for Blood Lancets Proposed Rule The Food and Drug Administration (FDA) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III. FDA is 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 PMA requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the benefits to the public from the use of the device. 2016-03-03 2016 3 https://www.federalregister.gov/documents/2016/03/03/2016-04579/effective-date-of-requirement-for-premarket-approval-for-blood-lancets https://www.govinfo.gov/content/pkg/FR-2016-03-03/pdf/2016-04579.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) following the reclassification of multiple use blood lancets for multiple patient use from class I to...

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