Regulatory Affairs In Brief
This article was originally published in The Gray Sheet
Executive Summary
HHS six-month rulemaking schedule: Device regulatory timelines appearing in the department's 1June 2004 semi-annual agenda include: a CMS notice clarifying factors used to determine "reasonable and necessary" in national coverage decisions (by August); a second notice of proposed rulemaking on appeals rights for Medicare suppliers challenging carrier determinations about billing privileges (by January 2005); a final rule on further safeguards for children in clinical trials evaluating FDA-regulated products (by November); a final rule strengthening quality levels of patient examination and surgeons' gloves (by December); "final action" on a 2001 NPRM for current good tissue practices in regulating tissue banks (December); an NPRM for good manufacturing practices of PET drugs (by January 2005); and a NPRM to upclassify pressure regulators for use of medical oxygen from Class I to Class II (by December)...