Federal Register #FDA-2026-N-5195

FDA Classifies Resorbable Calcium Salt Bone Void Filler with Aminoglycoside as Class II Device

This opportunity involves a regulatory classification action by the Food and Drug Administration (FDA), not a procurement request. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Product/Device Defined: - Resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial - Intended for treating bone voids and infection - OEMs and Vendors: - No specific OEMs or vendors are named, as this is a regulatory action - Key Requirements and Controls: - Device classified as Class II with special controls - Special controls include: - Clinical and animal performance testing - Non-clinical testing (biocompatibility, sterility, shelf-life) - Detailed labeling (material composition, absorption byproducts, technical parameters, expiration date, adverse events, warnings) - Post-market surveillance - Compliance with current good manufacturing practices - Codified under 21 CFR Part 888 - No procurement quantities, part numbers, or service requests are included, as this is not a solicitation for products or services.

Description

The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial into class II with special controls. This classification aims to ensure safety and effectiveness while reducing regulatory burdens, thereby improving access to innovative medical devices. The special controls include requirements for clinical performance testing, animal testing, non-clinical performance testing, biocompatibility, sterility, labeling, and post-market surveillance. The order is effective June 5, 2026, with classification applicable from May 17, 2022.

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