Transcription of Sheila Slides Japanese - jaame.or.jp
1 FDA . 510(k) .. 2012 10 .. 510(k) . 510(k) ? 510(k . IOM) .. CDRH .. 2. 510 k .. 510(k) ? 510(k . IOM) . October 2012 3. I . ( /GMP . / , ).. II . 510(k) .. 510(k) II . III . PMA) .. 4. FDA .. 510(k) . I II). 5.. 1976 .. 510(k) .. 6.. 7.. 8. 510(k) . FDA - 9 FDA .. FDA . MCS 510(k) .. FDA 510(k) .. 10(k) .. ASR XL .. 9. K) .. October 2012 10. CDRH 510(k) .. 2009 9 2010 8 . IOM).. 2009 9 FDA . 510(k) . 510(k) .. 2011 7 . 11. 510(k) . 510(k) .. CDRH .. 510(k) .. 510(k) . II . 510(k) .. 12. 510(k) .. FDA 510(k).
2 FDA II .. 13. FDA 510(k) .. CDRH 2011 7 29 . IOM 510(k) .. , 2011 9 16 . 2012 10 14. 2011 1 . CDRH510 k) 25 .. MedicalProductsandTobacco/CDRH/ . ctsandTobacco/CDRH/ 2012 10 15.. CDRH . 2012 10 16. 510(k) . 2012 10 17.. CDRH .. FDA .. CDRH . 2012 10 18.. CDRH .. 2012 10 19.. CDRH 510(k) .. October 2012 20.. CDRH .. CDRH .. 2012 10 21.. CDRH .. CDRH .. 2012 10 22.. 510(k) .. III . II . CDRH CDRH .. 23. 2012 10 .. ( ) . III PMA II .. 2012 10 24.. 510(k) : 510(k) .. 510(k) .. Guidance/ 2011 11 . 2012 7 . 2012 10 25.
3 FDA .. 26.. 13 .. oductsandTobacco/CDRH/ 27. October 2012 28. 510 k .. FDA .. III . 10 1 FDA . FDA 5 200 . FDA CDRH . October 2012 29.. 30.. H/ . Publics-Health-The-FDA-510k-Clearance-Pr ocess-at-35- : . ProductsandTobacco/CDRH/ 31.. 32.. FDLI).. Sheila [at] 2012 10 33.
