Medical Waste Sharps Containers and Secondary Sharps Containers - Design, Testing, and Labeling Requirements
This guidance pertains to sharps containers and secondary sharps containers used for medical waste disposal. Secondary containers are specifically designed to hold sharps containers when leakage is possible.
What You Need to Know? 👇
What are the key design requirements for sharps containers under FDA 510(k) submissions?
Sharps containers must be closable, puncture resistant, leakproof on sides and bottom, properly labeled with biohazard warnings, maintain stable upright position, and not include features to bend, break, or shear needles.
How does FDA clearance relate to OSHA compliance for sharps containers?
FDA 510(k) clearance doesn’t guarantee OSHA compliance. FDA evaluates infection control features while OSHA enforces workplace safety regulations. Both agencies work together but have separate enforcement authorities and requirements.
What classification and regulatory pathway applies to sharps containers?
Sharps containers are typically classified as Class II accessories to hypodermic needles or blood collection devices, requiring 510(k) premarket notification. They fall under panel 80 with product code FMI.
Are there specific standards that sharps containers must meet for FDA submission?
No FDA regulatory standards exist, but applicants may reference OSHA Bloodborne Pathogen regulations (29 CFR 1910.1030), British Standard BS 7320:1990, Australian Standard AS 4031-1992, or emerging ASTM standards.
What testing and validation data must be included in a 510(k) submission?
Submissions must include quantitative specifications and test methods for impact resistance, puncture resistance, leak resistance, stability, capacity, overfill detection, and other relevant features with objective pass-fail criteria.
Can manufacturers claim FDA approval in their sharps container marketing materials?
No, labeling cannot state the device is “FDA approved or cleared.” Manufacturers may claim OSHA Bloodborne Pathogen regulation compliance if permitted under OSHA regulations and statutes.
What You Need to Do 👇
Recommended Actions
- Develop comprehensive test protocols for all design specifications
- Prepare detailed documentation of materials and construction methods
- Ensure all required labeling elements are included
- Conduct comparative analysis with legally marketed devices
- Prepare 510(k) submission with all required design validation test results
- Include detailed specifications for all safety features
- Ensure compliance with OSHA regulations for bloodborne pathogens
- Prepare Safety and Effectiveness statement or summary as per 21 CFR 807.92 or 807.93
- Submit duplicate copies to FDA Document Mail Center
- Verify no claims of FDA approval are made in marketing materials
Key Considerations
Non-clinical testing
- Impact resistance testing required with specified pass-fail criteria
- Puncture resistance testing for base, sides, closure, and top
- Leak resistance testing for sides and bottom
- Stability testing for maintaining upright position
- Testing for safe transportation features
- Capacity validation
Human Factors
- Must be designed to easily and safely determine if container is full
- Must not require employees to reach by hand into container for reusable sharps
- Must maintain stable, upright position
- One-handed technique required for needle recapping features
Labelling
- Must include biohazard warning labels
- Labels must be fluorescent orange or orange-red with contrasting lettering
- Must include disposal procedures
- Must include assembly/mounting instructions
- Must include operating instructions
- General labeling requirements under 21 CFR 801
Safety
- Must be closable
- Must be puncture resistant
- Must be leakproof on sides and bottom
- No features to bend, break, or shear needles
- Must minimize aerosolization
Other considerations
- Cannot claim FDA approval in labeling or promotional material
- Class II device classification
- Must provide comparison to legally marketed devices
- Devices that remove sharps from needle hub using electrical charge or heat are Class III
Relevant Guidances 🔗
- Labeling Requirements and Recommendations for Medical Devices
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Human Factors Information Needed in Medical Device Marketing Submissions (Draft)
Related references and norms 📂
- BS 7320:1990: Specification for Sharps Containers
- AS 4031-1992: Non-Reusable Containers for the Collection of Sharps Medical Items Used in Health Care Areas
- ASTM Task Force F04.65.01: Standard for puncture resistance