PMA Application Methods - Product Development Protocol

In the product development protocol (PDP) method for gaining marketing approval, the clinical evaluation of a device and the development of necessary information for marketing approval are merged into one regulatory mechanism.

Ideal candidates for the PDP process are those devices in which the technology is well established in industry. The PDP process provides the manufacturer with the advantage of predictability once the agreement has been reached with FDA.

The PDP allows a sponsor to come to early agreement with FDA as to what would be done to demonstrate the safety and effectiveness of a new device.

Early interaction in the development cycle of a device allows a sponsor to address the concerns of the FDA before expensive and time consuming resources are expended.

The PDP is essentially a contract that describes the agreed upon details of design and development activities, the outputs of these activities, and acceptance criteria for these outputs.

It establishes reporting milestones that convey important information to the FDA as it is generated, where they can be reviewed and responded to in a timely manner.

The sponsor would be able to execute their PDP at their own pace, keeping FDA informed of its progress with these milestone reports. A PDP that has been declared completed by FDA is considered to have an approved PMA