 CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products.CDRH also conducts limited amounts of direct product testing.Clearance requests are for medical devices that prove they are "substantially equivalent" to the predicate devices already on the market.