The FDA’s device center reported the addition of four device types to the ranks of class II devices, including one each for de novo petitions by Apple Inc., of Cupertino, Calif., and Roche Molecular Systems Inc., of Pleasanton, Calif.

CAJICA, Colombia – In a move to reduce bureaucratic procedures and fight backlogs, the Brazilian health care surveillance agency, Anvisa, softened its rules for the marketing authorization of class II medical devices in the Latin American country.