Higher standards for device approval?

Group Calls for Higher Standards for Device Clearances, Approvals
The FDA is being pressured from within to adopt device approval standards similar to those used for drugs. Claiming that weaknesses in the agency’s device approval and clearance process have allowed potentially ineffective devices on the market, a recently published article co-authored by Peter Lurie, a senior adviser in the FDA’s Office of Compliance, asks Congress to raise the approval standards for devices to more closely match those required for drugs. Lurie wrote the article as deputy director of Public Citizen’s Health Research Group before FDA Commissioner Margaret Hamburg hired him last year.
Devices & Diagnostics Letter