Senate Requests Performance Data from FDA on De Novo Devices

A Senate appropriations committee is requesting the FDA to provide documentation on de novo device approvals, classifications and postmarket surveillance standards.

The committee said it was concerned that the agency is not providing information on how it is meeting timelines established by Congress.

Under a manager’s amendment to the 2017 Agriculture/FDA Appropriations bill, the Senate Appropriations Committee requested the FDA to report back to Congress in 90 days on:

• The number of de novo requests submitted to the FDA;
• The number of requests for 513(g) risk classifications of devices and the number the agency has met the 60-day requirement;
• The number of orders for postmarket device surveillance under Sec. 522 for which the agency has responded within 60 days.

Last year, during the MDUFA IV Session, the agency admitted to meeting its 120 day target for 40 percent of de novo applications (IDDM, Nov. 16, 2015).

Earlier this month the agency finalized guidance on its Section 522 surveillance program (IDDM, May 16).

The bill can be found here: www.fdanews.com/05-26-16-2017AgricultureAppropriationsBill.pdf. — Joya Patel