On January 27, the House approved, 333-0, a bill (H.R. 3493) to make technical corrections to the Medical Device User Fee and Modernization Act of 2002 (P.L. 107-250). The Senate approved a similar bill (S. 1881) on November 25, 2003, (see The Source, 11/26/03).
In addition to making technical changes, the measure would require the Secretary of Health and Human Services to submit a report to Congress on the availability of medical devices intended for the treatment or diagnosis of diseases and conditions that affect children. In the report, the Secretary should include recommendations on how to encourage the invention and development of such devices.
Rep. James Greenwood (R-PA), the sponsor of H.R. 3493 and the original bill, said that the technical clarifications “will allow the FDA to continue to reduce review times [of medical devices], increase the efficiency of its operations and allow these wonderful technologies to be delivered to patients more quickly.”
Rep. Anna Eshoo (D-CA) agreed. “This ‘Technical Corrections Act’ is an important bill because it is ultimately…about patients, and it will implement the Medical Device User Fee and Modernization Act as Congress fully intended.”
