FDA simplifies medical device review process
The New York Times reports the US Food and Drug Administration (FDA) has undertaken steps to streamline the review process for some lower-risk medical devices.
Federal health officials have imposed 25 changes to the device-approval process, including a shorter approval process requiring companies to demonstrate that a product is “substantially equivalent” to an existing one on the market and does not require human testing.
However, the new approval process has been criticised by experts who say it will allow the marketing of unsafe products.
Decisions on contentious issues that medical device makers feared could slow the approval of new products will also be deferred.
The FDA said it would ask the Institute of Medicine for comment on seven proposals, including the creation of a new category of devices that would require more data for approval.