The FDA and the European Community have both concluded that the decision to review a new product as a drug or a device shall be made on the basis of the primary intended function of the device. Thus,
if an intravascular catheter is coated with a "hemocompatible" coating, the catheter will be reviewed as a device. The catheter's primary purpose is to serve as a conduit for the delivery and removal of
fluids. The coating aids in the performance of this primary function. On the other hand, a wound care product that incorporates an antimicrobial agent is reviewed as a drug, as the primary intended use of the
product is to control infection. As far as the EU is concerned, all products that incorporate a medicine are considered Class III devices and require a clinical trial. The FDA doesn't necessarily require that
all coated devices be evaluated by a clinical trial. Clinical trials are required to substantiate clinical claims. Lesser claims can be substantiated by bench and pre-clinical data. There are basically 3
components of a coated device: The device; the coating vehicle, or matrix; and the active medicinal agent. In order to demonstrate the safety and efficacy of a coating, all 3 elements and their interrelationships
have to be evaluated. Coatings often require solvents, and the effects of the solvents on the substrate device surface and the active medicinal agent have to be evaluated, as does the effect of any residual solvent on
the patient. Aqueous-based coatings present lesser problems in relation to their effects on other elements of the system, but require careful analysis to assure that they adhere to the substrate and aren't dislodged
during insertion procedures. Sterilization is a harsh process that can inactivate medicinal agents or change the physical properties of the coating matrix and substrate. Therefore, all evaluations have to be
made after the coated device is sterilized. Testing can be minimized by the selection of the appropriate coating components. Use of a matrix and / or medicinal agent that has a documented history of safe and
effective use can eliminate the need for testing, provided the matrix and agent have been used for similar applications in the past. Phil Triolo and Associates can suggest coatings that will meet your customers' needs
while minimizing testing requirements. It can suggest, and when necessary, develop test methods to evaluate the coating's safety and efficacy. The results can then be incorporated into your regulatory
submission, or form the basis for a submission written by Phil Triolo and Associates |
