federal_register: 01-22577

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
01-22577 Medical Devices; Exemption From Premarket Notification Requirements; Class I Devices Rule In the Federal Register of July 25, 2001 (66 FR 38786), the Food and Drug Administration (FDA) amended its medical device classification regulations for class I devices to specifically add a reference to the general limitations on exemptions from premarket notification requirements from each generic device classified as exempt in each section. As published, an exemption from the premarket notification requirements and a reference to the general limitations language was inadvertently added to 12 device classifications that should not include the reference. These devices are not exempt from the requirements of premarket notification. This document corrects those errors. 2001-09-10 2001 9 https://www.federalregister.gov/documents/2001/09/10/01-22577/medical-devices-exemption-from-premarket-notification-requirements-class-i-devices https://www.govinfo.gov/content/pkg/FR-2001-09-10/pdf/01-22577.pdf Health and Human Services Department; Food and Drug Administration 221,199 In the Federal Register of July 25, 2001 (66 FR 38786), the Food and Drug Administration (FDA) amended its medical device classification regulations for class I devices to specifically add a reference to the general limitations on exemptions from...

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