Справочник Пользователя для Microsoft Corporation NHL-8X
[ 193 ]
Message from the FDA
)'$VKDUHVUHJXODWRU\UHVSRQVLELOLWLHVIRUZLUHOHVVSKRQHVZLWKWKH)HGHUDO
&RPPXQLFDWLRQV&RPPLVVLRQ)&&$OOSKRQHVWKDWDUHVROGLQWKH8QLWHG6WDWHV
PXVWFRPSO\ZLWK)&&VDIHW\JXLGHOLQHVWKDWOLPLW5)H[SRVXUH)&&UHOLHVRQ)'$
DQGRWKHUKHDOWKDJHQFLHVIRUVDIHW\TXHVWLRQVDERXWZLUHOHVVSKRQHV)&&DOVR
UHJXODWHVWKHEDVHVWDWLRQVWKDWWKHZLUHOHVVSKRQHQHWZRUNVUHO\XSRQ:KLOHWKHVH
EDVHVWDWLRQVRSHUDWHDWKLJKHUSRZHUWKDQGRWKHZLUHOHVVSKRQHVWKHPVHOYHVWKH
5)H[SRVXUHVWKDWSHRSOHJHWIURPWKHVHEDVHVWDWLRQVDUHW\SLFDOO\WKRXVDQGVRI
WLPHVORZHUWKDQWKRVHWKH\FDQJHWIURPZLUHOHVVSKRQHV%DVHVWDWLRQVDUHWKXVQRW
WKHVXEMHFWRIWKHVDIHW\TXHVWLRQVGLVFXVVHGLQWKLVGRFXPHQW
3. What kinds of phones are the subject of this update?
7KHWHUPZLUHOHVVSKRQHUHIHUVKHUHWRKDQGKHOGZLUHOHVVSKRQHVZLWKEXLOWLQ
DQWHQQDVRIWHQFDOOHGFHOOPRELOHRU3&6SKRQHV7KHVHW\SHVRIZLUHOHVVSKRQHV
FDQH[SRVHWKHXVHUWRPHDVXUDEOHUDGLRIUHTXHQF\HQHUJ\5)EHFDXVHRIWKHVKRUW
GLVWDQFHEHWZHHQWKHSKRQHDQGWKHXVHU·VKHDG7KHVH5)H[SRVXUHVDUHOLPLWHGE\
)HGHUDO&RPPXQLFDWLRQV&RPPLVVLRQVDIHW\JXLGHOLQHVWKDWZHUHGHYHORSHGZLWK
WKHDGYLFHRI)'$DQGRWKHUIHGHUDOKHDOWKDQGVDIHW\DJHQFLHV:KHQWKHSKRQHLV
ORFDWHGDWJUHDWHUGLVWDQFHVIURPWKHXVHUWKHH[SRVXUHWR5)LVGUDVWLFDOO\ORZHU
EHFDXVHDSHUVRQ
V5)H[SRVXUHGHFUHDVHVUDSLGO\ZLWKLQFUHDVLQJGLVWDQFHIURPWKH
VRXUFH7KHVRFDOOHGFRUGOHVVSKRQHVZKLFKKDYHDEDVHXQLWFRQQHFWHGWRWKH
WHOHSKRQHZLULQJLQDKRXVHW\SLFDOO\RSHUDWHDWIDUORZHUSRZHUOHYHOVDQGWKXV
SURGXFH5)H[SRVXUHVIDUEHORZWKH)&&VDIHW\OLPLWV
4. What are the results of the research done already?
7KHUHVHDUFKGRQHWKXVIDUKDVSURGXFHGFRQIOLFWLQJUHVXOWVDQGPDQ\VWXGLHVKDYH
VXIIHUHGIURPIODZVLQWKHLUUHVHDUFKPHWKRGV$QLPDOH[SHULPHQWVLQYHVWLJDWLQJWKH
HIIHFWVRIUDGLRIUHTXHQF\HQHUJ\5)H[SRVXUHVFKDUDFWHULVWLFRIZLUHOHVVSKRQHV
KDYH\LHOGHGFRQIOLFWLQJUHVXOWVWKDWRIWHQFDQQRWEHUHSHDWHGLQRWKHUODERUDWRULHV
$IHZDQLPDOVWXGLHVKRZHYHUKDYHVXJJHVWHGWKDWORZOHYHOVRI5)FRXOGDFFHOHUDWH
WKHGHYHORSPHQWRIFDQFHULQODERUDWRU\DQLPDOV+RZHYHUPDQ\RIWKHVWXGLHVWKDW
VKRZHGLQFUHDVHGWXPRUGHYHORSPHQWXVHGDQLPDOVWKDWKDGEHHQJHQHWLFDOO\
HQJLQHHUHGRUWUHDWHGZLWKFDQFHUFDXVLQJFKHPLFDOVVRDVWREHSUHGLVSRVHGWR
GHYHORSFDQFHULQWKHDEVHQFHRI5)H[SRVXUH2WKHUVWXGLHVH[SRVHGWKHDQLPDOVWR
5)IRUXSWRKRXUVSHUGD\7KHVHFRQGLWLRQVDUHQRWVLPLODUWRWKHFRQGLWLRQV
XQGHUZKLFKSHRSOHXVHZLUHOHVVSKRQHVVRZHGRQ·WNQRZZLWKFHUWDLQW\ZKDWWKH
UHVXOWVRIVXFKVWXGLHVPHDQIRUKXPDQKHDOWK
7KUHHODUJHHSLGHPLRORJ\VWXGLHVKDYHEHHQSXEOLVKHGVLQFH'HFHPEHU
%HWZHHQWKHPWKHVWXGLHVLQYHVWLJDWHGDQ\SRVVLEOHDVVRFLDWLRQEHWZHHQWKHXVH
RIZLUHOHVVSKRQHVDQGSULPDU\EUDLQFDQFHUJOLRPDPHQLQJLRPDRUDFRXVWLF
QHXURPDWXPRUVRIWKHEUDLQRUVDOLYDU\JODQGOHXNHPLDRURWKHUFDQFHUV
1RQHRIWKHVWXGLHVGHPRQVWUDWHGWKHH[LVWHQFHRIDQ\KDUPIXOKHDOWKHIIHFWV
IURPZLUHOHVVSKRQH5)H[SRVXUHV+RZHYHUQRQHRIWKHVWXGLHVFDQDQVZHU
TXHVWLRQVDERXWORQJWHUPH[SRVXUHVVLQFHWKHDYHUDJHSHULRGRISKRQHXVHLQ
WKHVHVWXGLHVZDVDURXQGWKUHH\HDUV