New MedWatch codes coming

CDRH's Office of Surveillance and Biometrics (OSB) is set to release a new code structure for FDA's MedWatch 3500A forms in November, OSB policy analyst Terrie Reed says. "Updates to the codes are made on a continuous basis and made available to the public via the FDA CDRH Web site," she told "The Silver Sheet." However, "there is currently an initiative between CDRH and the National Cancer Institute Enterprise Vocabulary Service to improve the codes." Under the initiative, changes have included streamlining patient and device problem codes, mapping inactivated or merged terms to preferred terms, and providing information and forms that will assist MedWatch reporters in requesting new codes. Nikki Willett, VP of marketing & regulatory affairs at Pilgrim Software's Tampa, Fla., office, says the MedWatch code changes are part of industry's growing pains. "We're seeing a lot more combination products like drug delivery or drug-coded products, so that has added to the complexity of medical device adverse event reporting," she says. "In addition, there have been a lot of breakthroughs in leading-edge medical technology, providing more complexities in the kind of reporting, especially in the diagnostics industry. So [FDA has] had to go back and re-look at some of the things they've done in the past and kind of catch up with the times.