Mechanical ventilation innovations: the manufacturer's perspective.

Manufacturers develop products that fit the corporate vision and maximize their return on investment. The expense and time required by the FDA regulatory approval process have a negative impact on product innovation. I propose the following approach: Reduce the amount of documentation required for a PMA or 510(k). Reduce approval times through cooperative interaction among manufacturers, clinicians, and the FDA throughout the product-development process. Allow independent agencies to provide product approvals. Efficacy assessment guidelines should be a function of the level of risk and the claims made for the marked device.