USA - The US Food and Drug Administration (FDA) Proposes Standards for Medical Devices

The US Food and Drug Administration (FDA), Health and Human Services (HHS) has issued this notification concerning medical devices, orthopedic devices and classification of posterior cervical screw systems.

The FDA or Agency is proposing to classify posterior cervical screw systems into class II Medical Devices (special controls) and to continue to require premarket notification to provide a reasonable assurance of safety and effectiveness of the device.

A posterior cervical screw system is a prescription device used to provide immobilization and stabilization in the cervical spine as an adjunct to spinal fusion surgery. The term "posterior cervical screw systems" is used to distinguish these devices from currently classified pedicle screw spinal systems cleared for use in other spinal regions.

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including the issue of performance standards, post-market surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the Agency deems necessary to provide such assurance.

The brief of the regulation is as follows:

• In this draft, the FDA Panel recommended that posterior cervical screw systems be classified into class II (special controls).
• The FDA Panel also recommended that posterior cervical screw systems be classified into class II as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine and craniocervical junction:

(1) Traumatic spinal fractures and/or traumatic dislocations; instability or deformity;

(2) Failed previous fusions (e.g., pseudarthrosis);

(3) Tumors involving the cervical spine; and

(4) Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative  disease of the facets with instability.

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures, so that these can be taken up suitably.