Under tax reform legislation recently passed by Congress, a 20% tax on products made in domestic territories will adversely affect the many device firms with Puerto Rican plants that currently enjoy a lower, 4% tax rate on profits. And a second tax provision usually relied upon by medtech companies, the R&D tax credit, also loses ground under the final Senate bill passed Dec. 2.

Complete list of 103 domestic and 66 foreign device quality-related warning letters released in 2012.