Transport and Shipping of Diagnostic Specimen and Etiologic Agents

The proposed product, called Pro-Tech-Tube Infectious Shipper (PTTIF), will enable health care workers in military or commercial laboratories to ship diagnostic substances that may contain infectious microorganisms (including Level 1, 2, and 3 in the DoD Biological Defense Safety Program, Technical Safety Requirements) as FDA regulated biological products. Such products are not subject to current transportation dangerous goods regulations. Diagnostic specimen that may contain infectious microorganisms when placed in PTTIF are FDA regulated "biological products" as defined in 21 CFR part 600. FDA regulated biological products in quantities of less than 50 ml are not subject to 49 CFR Hazardous Materials Regulations. Properly placed in PTTIF, medical specimen of less than 50 mL are subject to the Safe Medical Devices Act of 1990 (SMDA), Good Manufacturing Practices (21 CFR 808, 812, 812 and 920) and the preponderance of regulations by FDA. Military and commercial labs will experience lower costs in preparation and shipping, and at the same time reduce the risk of exposure to workers in the chain of custody. PTTIF is a disposable device eliminating the likelihood of putrid contamination as a result of reuse. Intended use: 21 CFR para. 866.2900 (PTTIF is a) microbiobiological collection and transport specimen collecting chamber intended for medical purposes to preserve the viability of microorganisms in specimen during storage of specimen after their collection and during their transport from collection to testing.