FDA and Industry Devise "Least Burdensome" Device Approval Strategy

IMPLEMENTATION OF THE "LEAST BURDENSOME" CONCEPT prescribed by Sec. 205 of the FDA Modernization Act will affect "virtually all" of FDA's medical device premarket approval activities, agency officials pledge. Industry hopes the FDAMA provisions, which require the agency to consider the "least burdensome" means for making PMA and 510(k) determinations, will foster quicker product development times. FDA and industry recently released a least burdensome "concept and principles" document that recommends exploring alternatives to randomized, controlled trials to support product approvals. A least burdensome approach is expected to foster greater interaction between product sponsors and FDA reviewers and increased use of new communication tools provided under FDAMA. WARNING LETTERS: FDA requests outside certification from Somnus Medical for corrective actions to address QS reg deficiencies; Datascope VasoSeal ES complication rate claims are "false and misleading," agency says