FDA classifies an antibiotic-containing resorbable "bone void filler" as a Class II device — reducing burden while assuring safety (June 2026)
The U.S. FDA classified a "resorbable calcium salt bone void filler" containing a single approved aminoglycoside antibacterial (an orthopedic device) into Class II (special controls). It aims to provide a reasonable assurance of safety and effectiveness while reducing regulatory burden and enhancing patient access to innovative products.
Document overview (primary data)
- Document typeRule
- AgencyHealth and Human Services Department
- Citation91 FR 34148
Key points
- FDA classified an antibiotic-containing resorbable "calcium salt bone void filler" (orthopedic) as Class II
- Class II assures safety/effectiveness via "special controls" in addition to general controls
- The order identifies the special controls and codifies them (CFR)
- Aims to enhance patient access to innovative products by reducing regulatory burden
- An example of medical-device regulation setting the standing of a new device type
The U.S. Food and Drug Administration (FDA) issued an order classifying a "resorbable calcium salt bone void filler" containing a single approved aminoglycoside antibacterial into Class II (special controls) (a rule, June 5, 2026; an orthopedic device).
A bone void filler is an orthopedic material used to fill bone defects or voids. This product uses a resorbable (body-absorbable) calcium salt as its base and contains a single approved aminoglycoside antibacterial to help address infection.
FDA medical devices are classified by risk as Class I (low), II (moderate), or III (high). Class II assures safety and effectiveness by imposing "special controls" in addition to general controls. The order identifies the special controls that apply to this device type, which become part of the codified classification (Code of Federal Regulations).
The FDA stated that classifying the product into Class II will provide a reasonable assurance of safety and effectiveness, and that the action will also enhance patients' access to beneficial, innovative products, in part by reducing regulatory burdens. It is an example of medical-device regulation establishing the regulatory standing of a new device type.
Why it matters
An example of setting the regulatory standing (Class II, special controls) of a new orthopedic device. For readers in medical devices, orthopedics, and regulatory affairs, or developers entering the U.S. market, a useful read on the regulatory category.
FAQ
What is a bone void filler?
Sources (primary)
Source: Federal Register (federal documents, public domain). Links go to the official site.