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

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Contains Nonbinding Recommendations
Classification of Posterior Cervical
Screw Systems: Small Entity
Compliance Guide
Guidance for Industry and
Food and Drug Administration Staff
Document issued on May 4, 2020.
For questions about this document, contact Regulations, Policy, and Guidance Staff by email at
RPG@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.
Identify all comments with the docket number FDA-2015-N-3785. Comments may not be acted
upon by the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet. You may also send an e-mail request to
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number 20008 and complete title of the guidance in the request.

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1
Classification of Posterior Cervical
Screw Systems: Small Entity
Compliance Guide
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the requirements of the applicable
statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office
responsible for this guidance as listed on the title page.
I. 	Introduction
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.
FDA's guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and
should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in Agency guidance means that
something is suggested or recommended, but not required.
II. 	Background
Prior to the classification, FDA regulated posterior cervical screw systems as unclassified
preamendments devices requiring premarket notification (510(k)).
On April 9, 2009, FDA published an order under sections 515(i) and 519 of the FD&C Act
(515(i) order) for the submission of safety and effectiveness information on pedicle screw
spinal systems with certain indications for use (74 FR 16214). 	In response to that order,
FDA received a request from the Orthopedic Surgical Manufacturers Association (OSMA) to

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classify posterior cervical screw systems into class II (special controls). 	Because this request
was considered to be outside the scope of the 515(i) order related to pedicle screw spinal
systems, FDA requested that OSMA submit a separate petition for classification of posterior
cervical screw systems. OSMA submitted the requested petition on November 22, 2011,
under Docket No. FDA-2011-P-0851. FDA convened an advisory committee meeting of the
Orthopaedic and Rehabilitation Devices Panel (the Panel) regarding the classification of this
device type on September 21, 2012. At that meeting, the Panel recommended that posterior
cervical screw systems be classified as class II with special controls. On April 1, 2019, FDA
published a final rule to classify posterior cervical screw systems into class II (special
controls) (84 FR 12088).1
III. 	Classification of Posterior Cervical Screw Systems
A. 	Classification Regulation
The classification regulation for posterior cervical screw systems is 21 CFR 888.3075.2 The
regulation classifies posterior cervical screw systems (product code NKG) into class II
(special controls).
B. 	Identification of Posterior Cervical Screw Systems
Paragraph (a) of §888.3075 identifies posterior cervical screw systems.
C. 	Posterior Cervical Screw Systems Class and Special
Controls
Paragraph (b) of §888.3075 establishes the class and special controls for posterior cervical
screw systems.
While posterior cervical screw systems3 must comply with the special controls,4 it is not
expected that manufacturers of devices already on the market as of May 1, 2019, would need
to submit new 510(k)s, 510(k) amendments, or add-to-files to demonstrate conformance with
the special controls.5
D. 	Posterior Cervical Screw System Classification
Regulation Effective Date
The classification rule became effective May 1, 2019.
1 Available at https://www.regulations.gov/document?D=FDA-2015-N-3785-0009.
2 https://gov.ecfr.io/cgi-
bin/retrieveECFR?gp=1&SID=068f27da33775aedfe34920c57076d02&ty=HTML&h=L&mc=true&r=SECTIO
N&n=se21.8.888_13075
3 As identified in 21 CFR 888.3075(a)
4 Section 513(a)(1)(B) of the FD&C Act, 21 U.S.C. 360c(a)(1)(B)
5 84 FR 12088 at 12090, April 1, 2019

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E. 	Viewing the Posterior Cervical Screw System
Classification Regulation
The United States government provides an electronic version of the Code of Federal
Regulations (eCFR). The posterior cervical screw system regulation can be found in the
eCFR.6 The title number is 21. The section heading is 888.3075.
6 https://gov.ecfr.io/cgi-bin/ECFR?SID=faf9398779e536bc9e7700b3cbc2ed79&mc=true&page=simple