title: New FDA reporting rule means new concerns.
mesh_terms: D004282:Documentation; D004869:Equipment Safety / Q000592:standards; D006268:Health Facilities / Q000331:legislation & jurisprudence*; D016134:Organizational Policy; D011358:Product Surveillance, Postmarketing; D016730:Program Development; D011996:Records; D014481:United States; D014486:United States Food and Drug Administration