A02 Attachment 1 - Technology Readiness Level (TRL) (Reference only).pdf
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- Attached to
- Freeze-Dried Platelet Product for the Treatment of Trauma-Associated Blood Loss in Canines
- Solicitation number
- HT9427-26-RFI-703
- Issued by
- Not on record
About this file
This is an attachment defining Technology Readiness Levels (TRLs) for canine veterinary medical products, establishing a framework for evaluating product development maturity across four major activity categories.
The document presents a matrix with Technology Readiness Levels 5 through 8, structured around four major development activities: Manufacturing Development (M), Safety Studies in Canines (S), Efficacy Studies in Canines (E), and Regulatory Maturity with the FDA Center for Veterinary Medicine (R). At TRL 5, manufacturing consists of pilot lot production, initial safety and efficacy studies have been performed, and the sponsor has consulted FDA on the development plan. TRL 6 involves full-scale manufacturing processes, additional safety studies conducted with FDA CVM guidance, refined efficacy studies addressing dose and administration routes, and FDA update submissions. TRL 7 requires commercial-scale batch production for process validation, safety studies using commercially-manufactured material, pivotal efficacy studies supporting label indication, and FDA data submission for marketing approval review. TRL 8 represents full maturity with validated manufacturing processes, well-characterized safety profile, demonstrated efficacy in controlled studies, and FDA approval or enforcement discretion decision. This framework establishes clear developmental milestones required for canine veterinary medical products to progress from initial concept through FDA regulatory approval.
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Other files
| File | Type | Posted |
|---|---|---|
| A02 RFI for FREEZE-DRIED PLATELET CANINE_wgh.pdf | ||
| A02 Attachment 2 - Company Product Information.docx | DOCX document |
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Text version
TECHNOLOGY READINESS LEVELS FOR CERTAIN CANINE VETERINARY MEDICAL PRODUCTS
Major Activity Technology Readiness Level
- 5 6 7 8
M - Manufacturing Development
Pilot lot has been produced to support initial safety and efficacy studies
Processes for full-scale manufacturing have been developed
Batches have been made at commercial scale for process validation and to support studies of safety and pivotal efficacy
Processes have been validated
S - Safety studies in Canines
Initial safety study has been performed and data support further development
Additional safety studies have been performed with FDA CVM guidance (if available) and data support further development
Safety studies have been performed with material made at commercial scale
Safety has been well-characterized; product has been deemed suitable for use
E – Efficacy studies in Canines
Initial efficacy study has been performed and data support further development
Additional efficacy studies have been performed to refine dose, route, and timing of administration and data support further development
Pivotal efficacy studies have been performed to support label indication
Efficacy has been demonstrated in well-controlled studies; product has been deemed suitable for use
R - Regulatory maturity (FDA Center for Veterinary Medicine)
Sponsor has consulted FDA on product development plan
Sponsor has submitted updates to the FDA
Sponsor has submitted data to FDA for review and possible marketing approval
FDA has either approved the product or decided to apply “enforcement discretion after FDA review of risk information”
Attachment 1 - TRL
File details come from the government source that posted it. Updated .