federal_register: E8-29413

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
E8-29413 Draft Guidance for Industry and Food and Drug Administration Staff; Submission and Review of Sterility Information in Premarket Notification Submissions for Devices Labeled as Sterile; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." This draft guidance document updates and clarifies the procedures for reviewing premarket notification submissions (510(k)s) for devices labeled as sterile, particularly with respect to sterilization technologies FDA considers novel, and the information that should be included in 510(k)s for devices labeled as sterile. 2008-12-12 2008 12 https://www.federalregister.gov/documents/2008/12/12/E8-29413/draft-guidance-for-industry-and-food-and-drug-administration-staff-submission-and-review-of https://www.govinfo.gov/content/pkg/FR-2008-12-12/pdf/E8-29413.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." This draft guidance...  

Links from other tables