On April 23, 2014, the Food and Drug Administration (FDA) proposed a new voluntary program to accelerate approval of devices that show promise in treating debilitating or life-threatening conditions for which a need has not been met. Called an Expedited Access Premarketing Approval (PMA) or EAP, this program would allow sponsors to market devices that treat these conditions more quickly.
According to the draft guidance, all of the current processes and regulations will remain in place. For instance, the following still apply:
· Sponsors must register and list the device if they can demonstrate that it constitutes a low risk, is not subject to premarketing evaluation, and complies with good manufacturing practices (all Class I devices).
· For a slightly higher-risk device not subject to PMA application rules, sponsors must submit a premarketing notification (501[k]) to demonstrate that the device is equivalent to an existing one marketed before May 28, 1976 (some Class I and some Class II devices).
· Sponsors looking to market a device for which studies pose a significant risk must submit either a PMA application or an Investigational Device Exemption (IDE) on the basis of the risk profile (some Class II and all Class III devices).
However, under the guidance, the FDA can hasten approval of a PMA or an IDE if the sponsor can demonstrate that the device meets the following criteria:
· The device treats a life-threatening or debilitating condition.
· The device fills a current gap in treatment, such as treating a condition for which no effective treatment is available or providing more effective treatment than what is currently available. Also, the sponsor should be able to demonstrate that making the device available would be in the best interests of the patient.
· The sponsor submits a data development plan.
Participation in the program is voluntary and at the agreement of both the sponsor and the FDA. For those devices that receive the designation, the FDA will collaborate more actively with sponsors during the review of PMA and IDE applications. As such, they may involve senior managerial members and other people familiar with review of these devices. When necessary, they might also appoint a case manager.
The data development plan is the one of the newest aspects of the process. This plan would be developed through active collaboration between the sponsor and the FDA. This plan would contain an outline of all data to be collected during the premarketing process and postmarketing surveillance. The FDA would also help the sponsor to determine which data should be collected before marketing and which can be collected after marketing.
Some factors that the FDA will consider when granting an EAP for an IDE and a PMAs include whether the premarketing data suggest that serious harm is unlikely to result and whether the device is implantable. They will take into account whether the sponsor has a history of high quality standards. Other considerations include whether a Data Safety Monitoring Board will monitor the postmarketing studies and timely postmarketing data would easily identify any adverse events and reactions. They will also examine whether patient labeling that includes training to decrease potential risks for users is issued by the sponsor and what the patients’ tolerance levels are with respect to the device.
The threshold of acceptable data for the FDA to approve a device with an EAP designation also might be lower. For instance, the FDA might be more willing to approve a device with less conclusive data if the benefits outweigh the risks. Similarly, the FDA might allow less information on manufacturing in a PMA if the sponsor has a solid history of providing quality and there are no new quality issues. The FDA may also review the manufacturing information and choose not to inspect some of the sites producing the device until after the approval.
However, the provided data on safety, efficacy, and manufacturing must still meet the minimum legal standards. The FDA will also require the sponsor to submit postapproval studies. If the data suggest that the device is less than beneficial, the FDA can withdraw approval. Nonetheless, this option may allow sponsors to get devices that treat life-threatening or debilitating diseases on the market more rapidly.
For further reading
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm