Regulatory & Quality Framework
Arvix Biologics products are developed and distributed within a comprehensive regulatory and quality framework designed to support hospital review and institutional use.
Framework Overview
Where applicable, products are regulated as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) under 21 CFR Part 1271. Arvix maintains systems designed to support donor eligibility determination, tissue processing controls, traceability, and documentation requirements relevant to hospital review and institutional use.
Regulatory Compliance
Systems designed to address HCT/P regulatory requirements including donor eligibility, current good tissue practice, and establishment registration.
Quality Systems
Comprehensive quality management encompassing all aspects of tissue recovery, processing, storage, and distribution with documented procedures.
Traceability
Comprehensive tracking system maintaining donor-to-distribution records to support adverse event investigation and product recall capabilities.
HCT/P 361 Positioning
Where applicable, Arvix Biologics products are regulated as Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) under 21 CFR Part 1271. Products meeting the criteria outlined in 21 CFR 1271.10(a) are regulated 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 while meeting regulatory definitions for minimal manipulation.
Homologous Use
Products intended for applications consistent with the tissue's natural function, supporting regulatory positioning for homologous use.
No Systemic Effect
Products designed for topical application without dependence on systemic metabolic activity for their primary function.
Quality Systems & Controls
Donor Screening & Testing
Comprehensive donor eligibility determination systems designed to identify and exclude donors with risk factors for relevant communicable diseases.
Processing Controls
Controlled environment processing with documented procedures, environmental monitoring, and personnel training designed to reduce contamination risk.
Quality Control Testing
Release testing protocols designed to verify product quality and safety before distribution to clinical sites.
Sterility Testing
Testing performed according to established pharmacopeial methods to verify absence of viable microorganisms.
Bioburden Assessment
Monitoring of microbial load throughout processing to support contamination control strategies.
Tissue Integrity
Assessment of tissue characteristics and structural integrity to verify processing outcomes.
Traceability & Documentation
Comprehensive Tracking System
Arvix maintains a comprehensive tracking system designed to maintain donor-to-distribution records. Documentation is structured 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.
Adverse Event Reporting
Systems for receiving, investigating, and reporting adverse reactions and product deviations in accordance with regulatory requirements.
Reporting Channels
Multiple channels for healthcare providers to report adverse events or product concerns.
Investigation
Documented investigation procedures to determine root cause and appropriate corrective actions.
Regulatory Reporting
Timely reporting to FDA and other relevant authorities as required by regulations.
Customer Notification
Communication protocols to notify affected customers and support corrective actions.
Documentation Standards
Standard Operating Procedures
Documented procedures for all critical processes with version control and training requirements.
Batch Records
Complete production records for each lot documenting all processing steps and controls.
Quality Records
Testing results, environmental monitoring data, and quality control documentation.
Training Records
Personnel qualification and competency assessment documentation for all staff.
Need Regulatory Documentation?
Our regulatory team can provide detailed documentation to support your institutional review and evaluation processes.
Contact Regulatory Team