U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide Guidance for Industry and Food and Drug Administration Staff May 2020

Final
Docket Number:
FDA-2015-N-3785
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-N-3785.