Structured Supplier Evaluation Process
Following credential confirmation through the Provider Credential Verification Portal , licensed healthcare professionals may elect to participate in a structured evaluation discussion directly with the manufacturer.
The purpose of this discussion is to review sourcing transparency, laboratory governance standards, documentation safeguards, and regulatory positioning within a defined professional framework.
This evaluation framework applies to product categories outlined within the Biologic Product Portfolio .
Documentation-First Review Structure
Evaluation discussions are structured around documentation, not marketing claims. Topics may include:
- Manufacturer governance and laboratory oversight standards
- Donor eligibility determination documentation (Subpart C)
- Processing methodology and quality control safeguards
- Lot-level traceability and chain-of-custody controls
- Regulatory positioning under 21 CFR Part 1271 Section 361
- Manufacturing controls under Current Good Tissue Practice (cGTP)
Applicable Biologic Categories
Regulatory Context Clarification
Discussion may include classification considerations such as minimal manipulation , homologous use , and documentation standards defined within the 21 CFR Part 1271 Subparts A–D regulatory structure .
Classification analysis may also reference the Section 361 vs Section 351 distinction and related FDA enforcement considerations .
The evaluation process supports institutional due diligence and internal compliance assessment.
Defined Professional Boundaries
Supplier evaluation discussions do not include clinical protocol guidance, treatment recommendations, dosing instruction, or representation of therapeutic outcomes.
Clinical decisions remain solely within the scope of the licensed healthcare professional.
Post-Evaluation Determination
Participation in an evaluation discussion does not create purchasing obligation or supplier commitment.
Professionals independently determine whether to proceed with a supplier relationship following documentation review.
Initiate Structured Evaluation
Structured supplier evaluation is available exclusively to verified licensed healthcare professionals.
Educational reference only. Supplier evaluation discussions do not constitute medical advice, regulatory approval, or product endorsement. Certain materials discussed may be regulated under 21 CFR Part 1271 Section 361. Establishment registration does not constitute FDA approval, clearance, or evaluation of safety or effectiveness.