U.S. Food and Drug Administration: Medical Device Pilot Programs and the New Purple Book of Biosimilars

The U.S. Food and Drug Administration (FDA) has several pilot programs underway that should make many medical device applications simpler and faster. For premarket notifications, the 510(k) eSubmissions Program will guide companies in putting together and submitting a 510(k) application — resulting in a faster review process. The pilot, initiated in July 2014, is undergoing significant expansion. The program will eventually cover more types of device submissions, including Premarket Approval (PMA) applications.


Another FDA pilot program is the Center for Devices and Radiological Health’s (CRDH’s) Submission Tracker pilot, initiated in August 2014. This web-based portal will allow companies to check on the progress of their 510(k) submission as it goes through the FDA’s review process. The current pilot provides information like submission status and dates that the device passed important review milestones.


A third pilot program, announced on August 15, 2014, will inform future guidance on the use of medical device development tools (MDDTs). Examples of MDDTs include biomarker tests and nonclinical assessment models. Previously, a MDDT would have to be re-evaluated every time it was used in a different clinical setting or with a different product, often resulting in redundant reviews of the same MDDT. Now, a MDDT that has been qualified for use in one context can be re-used for the same purpose in the future. Expanded guidance on this policy should result in more efficient and faster device development.


In pharmaceutical news, the FDA has recently published its first ‘Purple Book.’ The Purple Book parallels the FDA’s Orange Book, which lists FDA approved drugs that have approved generics or maintain patent exclusivity. The Purple Book will include information on each FDA approved biologic’s name, license date and biosimilar or interchangeable equivalent(s). The FDA has established four levels of biosimilar interchangeability, ranging from “not similar” to “highly similar with fingerprint-like similarity.”