FDA Medical Device Approval Process

The development of a medical device from concept to product launch typically takes between 4-10 years and costs between $5 and $300 million dollars depending on the complexity of the device and required regulatory process. There are approximately 40 PMA devices approved each year by the FDA and an additional 3,000 510 (k) clearances. There are FDA user fees required when a technology is submitted for regulatory review. These user fees support the operation of the FDA and range from ~$200K for a PMA submission down to ~$3,500 for a new 510 (k) submission. There are significantly reduced fees for an initial submission from a small business.

Proof of Concept in Man:	10-30 healthy subjects, safety studies.
Pivotal Trials:	75-400 subjects, study safety and preliminary evidence of efficacy in target indication.

Concept and Design includes robust due diligence such as detailed market analysis including competition and clinical need.

Pre-Clinical Development includes bench testing, biocompatibility and other laboratory testing, and animal studies.

IDE Investigational device exemption is the regulatory authorization for the device to be used in a clinical study to collect safety and efficacy data. This data is required to support a Pre-market Approval (PMA) application or in some instances a Pre-market Notification [510(k)] submission to FDA.

510(k) Pre-market submission made to the FDA to demonstrate that the Class II device to be marketed is at least as safe and effective as substantially equivalent devices legally marketed in the US and supporting their claims.

Class II devices are complex, higher-risk devices that are not life-sustaining. They may be subject to special labeling, performance standards, post-market surveillance and possibly patient device registries.

PMA Pre-market approval is the process of gathering scientific evidence to assure that the Class III medical device is safe and effective for its intended use. An approved PMA is, in effect, a private license granting the applicant (or owner) FDA permission to market the device.

Class III support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, risk of illness or injury to the user.