federal_register: 2021-25381

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2021-25381 Effective Date of Requirement for Premarket Approval for Blood Lancets Rule The Food and Drug Administration (FDA, Agency, or we) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III. 2021-11-22 2021 11 https://www.federalregister.gov/documents/2021/11/22/2021-25381/effective-date-of-requirement-for-premarket-approval-for-blood-lancets https://www.govinfo.gov/content/pkg/FR-2021-11-22/pdf/2021-25381.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, Agency, or we) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) following the reclassification of multiple...

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