Description
This guidance covers emergency-use injectors submitted under a biologics license application (BLA), new drug application (NDA), or abbreviated new drug application (ANDA). The term “emergency-use injector” means injectors marketed with an emergency-use drug as a prefilled single entity combination product under 21 CFR 3.2(e)(1) or as a co-packaged combination product under 21 CFR 3.2(e)(2). Emergency-use injector includes pen injectors, autoinjectors, or on-body-wearable delivery systems for drugs for emergency treatment of conditions such as anaphylaxis, opioid overdose, poisoning, or severe hypoglycemia.
Scope & Applicability
Product Classes
3Injectors marketed with an emergency-use drug as a prefilled single entity combination product or co-packaged combination product.; Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Injectors for treatment of anaphylaxis used by patients or first responders.; Technical considerations for demonstrating reliability of emergency-use injectors.; Technical considerations for demonstrating reliability of these devices.
Stakeholders
2User who may have only one opportunity to use the product.
Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
7reliability includes accuracy, completeness, and traceability
Main Spring Geometry / Dimension contributing to failure
High Trigger Force Prevents Activation
statistically justified calculation required in the plan
Physicochemical characteristic used to assure product acceptability.
intended storage conditions throughout the proposed shelf-life
should be based on appropriate supportive stability data
Identified Hazards
Hazards
2Primary risk where functional failure modes prevent drug delivery.; The top event in the fault tree analysis for emergency-use injectors.; Top-level failure mode in reliability analysis
Vibration, shock, temperature extremes, and air particulates.
Related CFR Sections (3)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
- 21CFR4.4§ 4.4 How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?
(a) Under this subpart, for single entity or co-packaged combination products, compliance with all applicable current good manufacturing practice requirements for the combination product shall be achieved through the design and implementation of a current good manufacturing practice operating systemRead full regulation →
Related Warning Letters (10)
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CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
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Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
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Medinatura New Mexico, Inc.
- 2025-12-16
CGMP/Finished Pharmaceuticals/Adulterated
Sklar Personal Care Inc.
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
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- 2025-12-09
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See Also (8)
- Deciding When to Submit a 510(k) for a Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff (Status: Final)
- Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff (Status: Draft)
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (Status: Final)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (Status: Final)