Klobucher, Paulsen caution FDA on changing 510(K) system

Who says Republicans and Democrats can't agree on anything? Sen. Amy Klobuchar and Rep. Erik Paulsen, both of Minnesota, are cautioning the FDA against making changes to its product approval process that could threaten the medical device industry's position as a key source of U.S. exports. A key reason for the bipartisan cooperation: Minnesota boasts more than 400 medical device companies that together employ more than 50,000. Report

Suggested Articles

Takeda tapped Roche’s Foundation Medicine to develop tissue- and blood-based companion diagnostic tests for its portfolio of lung cancer therapies.

Cellex has announced plans to develop a rapid coronavirus test that people can fully perform at home, from sample collection to result, using an app.

More than 20 states either don’t release or have incomplete data on the rapid antigen tests now considered key to containing the coronavirus.