federal_register: 05-22069

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
05-22069 Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner." This guidance document has been developed as a special control guidance document to support the classification of the low energy ultrasound wound cleaner into class II (special controls). The device is intended for the cleaning and maintenance debridement of wounds. This guidance document describes a means by which the low energy ultrasound wound cleaner may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify the low energy ultrasound wound cleaner into class II (special controls). The guidance document is immediately in effect as the special control for the low energy ultrasound wound cleaner, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs). 2005-11-07 2005 11 https://www.federalregister.gov/documents/2005/11/07/05-22069/guidance-for-industry-and-food-and-drug-administration-staff-class-ii-special-controls-guidance https://www.govinfo.gov/content/pkg/FR-2005-11-07/pdf/05-22069.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner." This guidance document has been developed as a special control guidance...  

Links from other tables