Although seven potential zones of entrapment have been identified by FDA and HBSW, no dimensional guidance or test methods have yet been developed for Zones 5, 6, and 7. FDA recommends dimensional limits and testing for zones 1 through 4, because these zones were most frequently reported as the sites of entrapments. FDA will continue to monitor entrapments in all the zones and collaborate with HBSW on possible assessment and remedial action.
