Classification of posterior cervical screw systems: small entity compliance guide : guidance for industry and Food and Drug Administration staff

Classification of posterior cervical screw systems: small entity compliance guide : guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 4, 2020
Language(s):
English
Format:
Text
Subject(s):
Bone Screws
Cervical Vertebrae
Classification
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
On April 1, 2019, FDA published a final rule in the Federal Register entitled “Classification of Posterior Cervical Screw Systems” (84 FR 12088). This final rule created the classification regulation 21 CFR 888.3075 for posterior cervical screw systems and established special controls. FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28) to assist small entities to comply with the requirements established in 21 CFR 888.3075.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (3 pages)).
NLM Unique ID:
9918231199406676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918231199406676