Cov txheej txheem:

Daim ntawv 510k yog dab tsi?
Daim ntawv 510k yog dab tsi?

Video: Daim ntawv 510k yog dab tsi?

Video: Daim ntawv 510k yog dab tsi?
Video: Xwm Kab Yog Dab Tsi?: Hmoob Nkag Siab Yuam Kev Tag Lawm 2024, Kaum ib hlis
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A 510 (ib ) yog ib qho kev xa uas muaj cov ntaub ntawv xav tau hauv qab 21 CFR 807.87. Yog xav paub ntxiv txog kev tswj hwm lub moj khaum, cov cai, thiab cov kev coj ua hauv qab lub FDA 510 (k ) tshuaj xyuas, thov mus saib cov lus qhia The 510 (ib ) Kev Pabcuam: Kev ntsuas qhov sib npaug ntawm qhov kev ceeb toom ua ntej [ 510 (ib )].

Ib sab ntawm qhov no, daim ntawv 510k yog dab tsi?

A 510 (K ) yog premarket kev xa ua rau FDA los ua pov thawj tias cov cuab yeej yuav tsum tau ua lag luam tsawg kawg yog muaj kev nyab xeeb thiab siv tau zoo, uas yog, sib npaug ntau, rau cov khoom lag luam raug cai (21 CFR §807.92(a)(3)) uas tsis raug tso cai ua ntej muag khoom. Kawm ntxiv Nrhiav Database. Pab Download cov ntaub ntawv. 510k ua

Ib yam li ntawd, qhov tshwj xeeb 510k yog dab tsi? Tshwj xeeb 510 (k ) tso cai rau FDA thiab kev lag luam cia siab rau yav dhau los Lub Chaw Haujlwm saib xyuas cov ncauj lus kom ntxaws, yog qhov tsim nyog, yam tsis muaj kev hloov pauv cov cai lossis kev tswj hwm kev cai cuam tshuam nrog cov txheej txheem kev ceeb toom ua ntej raws li tshooj 510 thiab 513 ntawm FD&C Txoj Cai, thiab 21 CFR 807 Subpart E.

Yog li ntawd, koj npaj li cas 510 K?

Txhawm rau pib, ntawm no yog cov npe ntawm tag nrho cov seem uas yuav tsum tau ua rau 510 (k) xa:

  1. Pawg 1 – Daim Ntawv Npog.
  2. Pab Pawg 2 – Lwm Tus Saib Tau Li Cas.
  3. Pab Pawg 3 – Ntu ntu Templated.
  4. Pab Pawg 4 – Sib Piv Koj Cov Khoom Muag vs. Predicate(s)
  5. Pawg 5 – Ua kom muaj kev nyab xeeb ntawm tus neeg mob.
  6. Pawg 6 – Software thiab Electronics.
  7. Pawg 7 – Kev Ntsuas Kev Ua Haujlwm.

Qhov txawv ntawm 510k thiab PMA yog dab tsi?

A PMA yog qhov tob tshaj li ib 510k ua - nws yog siv los ua pov thawj tias lub cuab yeej tshiab muaj kev nyab xeeb thiab siv tau zoo rau cov neeg siv kawg thiab feem ntau yuav tsum muaj kev sim tshuaj nrog tib neeg cov neeg koom nrog rau kev sim kuaj.

Pom zoo: