Devices & Diagnostics Letter

Last week’s U.S. Supreme Court decision on the patent eligibility of a diagnostic could have ramifications for in vitro diagnostic (IVD) devicemakers, limiting investment in novel tests because of uncertainty about what is and is not patentable, a U.S. patent attorney tells D&DL.

Starting June 5, devicemakers audited according to internationally harmonized regulatory standards could be spared some annual FDA inspections, under a pilot program described in a final guidance.

Unlike a draft bill on device user fee reauthorization circulating in the House, draft legislative language published by the FDA does not incorporate GOP proposals to streamline the regulatory process and encourage business development (D&DL, March 19).

Boston Scientific’s investment in San Clemente, Calif.-based Cameron Health may pay off fairly soon, one analyst predicts.

Device-related adverse events would be tracked by the FDA’s Sentinel postmarket surveillance system if a new Senate bill becomes law.

The FDA has released a draft guidance aimed at encouraging the development of tests that allow more timely screening for tuberculosis.

Early goals of the newly formed International Medical Device Regulators Forum (IMDRF) include defining a common international “table of contents” for electronic submissions and designing a roadmap for implementation of a unique device identification system.

Initial FDA investigations of the ways people use and misuse medical devices — referred to as human factors testing — will center on infusion pumps, an FDA official says.