Regulatory & Quality by Design
Arvix products are developed within a comprehensive quality framework designed to meet regulatory requirements and support hospital compliance processes.
HCT/P 361 Positioning
Arvix Biologics products are regulated as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) under 21 CFR Part 1271. Our products meet the criteria outlined in 21 CFR 1271.10(a) for regulation solely under Section 361 of the Public Health Service Act.
HCT/P 361 Positioning
Arvix Biologics products are regulated as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) under 21 CFR Part 1271. Our products meet the criteria outlined in 21 CFR 1271.10(a) for regulation solely under Section 361 of the Public Health Service Act.
This regulatory pathway requires compliance with donor eligibility determination, current good tissue practice, establishment registration, and product listing requirements. Arvix maintains systems designed to address these regulatory obligations.
Minimal Manipulation
Processing methods designed to preserve tissue structure and characteristics
Homologous Use
Intended for wound coverage applications consistent with amnion membrane function
No Systemic Effect
Products applied topically without systemic metabolic activity dependence
Safety & Processing Standards
Comprehensive donor screening, testing, and processing controls designed to reduce contamination risk and ensure product safety.
Donor Screening
Comprehensive medical and social history review conducted by qualified personnel. Screening criteria designed to identify risk factors for relevant communicable diseases.
- •Medical record review
- •Physical assessment
- •Risk factor evaluation
Donor Testing
Required infectious disease testing performed using FDA-licensed, approved, or cleared donor screening tests. Testing conducted by laboratories certified under CLIA.
- •HIV-1/2 antibody and NAT
- •Hepatitis B and C testing
- •Additional required markers
Processing Controls
Controlled environment processing with documented procedures, environmental monitoring, and personnel training. Aseptic technique and contamination prevention protocols.
- •Cleanroom environment
- •Validated procedures
- •Environmental monitoring
Traceability & Documentation
Comprehensive tracking system maintaining donor-to-distribution records. Documentation designed to support adverse event investigation and product recall capabilities if needed.
Donor Records
Complete donor eligibility determination documentation including screening, testing, and assessment records maintained per regulatory requirements.
Processing Documentation
Batch records documenting all processing steps, environmental conditions, personnel, and quality control testing for each production lot.
Distribution Tracking
Records linking specific product lots to distribution locations, enabling rapid identification and communication in the event of safety concerns.
Labeling & UDI Readiness
Product labeling designed to meet regulatory requirements and support hospital inventory management and tracking systems.
Required Label Information
- Proper tissue identification and description
- Manufacturer name and contact information
- Lot number and expiration date
- Storage and handling instructions
- Biohazard and safety warnings
UDI Implementation
- Unique Device Identifier compliance readiness
- Machine-readable barcode formats
- GUDID database submission preparation
- Hospital inventory system compatibility
- Adverse event reporting support
Quality Management System
Comprehensive quality framework encompassing all aspects of tissue recovery, processing, storage, and distribution.
Standard Operating Procedures
Documented procedures for all critical processes with version control and training requirements.
Personnel Qualification
Training programs and competency assessment for all personnel involved in tissue handling.
Quality Control Testing
Release testing protocols including sterility, bioburden, and tissue integrity assessments.
Adverse Event Reporting
Systems for receiving, investigating, and reporting adverse reactions and product deviations.
Need detailed regulatory documentation?
Our VAC packet includes comprehensive regulatory positioning, quality system overview, and compliance documentation designed to support hospital review processes.