FDA classifies absorbable metallic bone screws as Class II devices
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The Food and Drug Administration has officially classified a specific type of medical implant called an “absorbable metallic bone fixation fastener” into Class II. This category is for moderate-risk devices that require special controls to ensure they are safe and effective.
Why it matters: This action clarifies the regulatory path for manufacturers making bone screws made of metals that dissolve in the body over time. It reduces the administrative burden on companies seeking to bring these implants to patients, potentially speeding up availability while maintaining safety standards through required testing and labeling.
Who it affects
- Medical device manufacturers producing absorbable metallic bone fixation fasteners
This information comes from a final order published by the Food and Drug Administration in the Federal Register; readers should consult the original document for full regulatory details.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document