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有關Premarket Notification 510(k) submissions for medical devices 文件,規定的20章節, 請看:- d' B* V& t) k/ T( u
Guidance for Industry and FDA Staff
* p6 P2 l$ I; E6 S" jFormat for Traditional and Abbreviated 510(k)s
, m1 Q0 o; H3 j8 X/ ~& t8 `Medical Device User Fee Cover Sheet (Form FDA 3601)
) r6 r' v$ O! o4 w* u4 f; Y( UCDRH Premarket Review Submission Cover Sheet
" {3 {1 y. F9 F510(k) Cover Letter , [5 _( {# G7 e
Indications for Use Statement
) T8 ~3 Z0 i" \510(k) Summary or 510(k) Statement
+ m3 M5 f; j5 y$ }4 z+ u! u- ]Truthful and Accuracy Statement
- ^, H, Q* r" t& pClass III Summary and Certification
! ?5 l0 e! v/ @" g( b/ a8 I- jFinancial Certification or Disclosure Statement
& q3 ]8 [! W# M, y9 t5 [Declarations of Conformity and Summary Reports
* F3 Q. V. y0 ^- D& P. ?Executive Summary
+ \/ C+ \+ J& PDevice Description
* T' \1 l7 B! V- @" a% nSubstantial Equivalence Discussion 0 G" e9 ]7 _5 C
Proposed Labeling
. q% m, Z, n0 M# N5 QSterilization and Shelf Life N& h& m# o* D D
Biocompatibility : t( [; H4 R/ g
Software . U! g2 V% n% o+ w
Electromagnetic Compatibility and Electrical Safety ) R: m# L. D+ d/ _+ H
Performance Testing – Bench , C, l1 v* ~/ c$ U& d
Performance Testing – Animal
z2 `4 N& {. A: P' q( L. NPerformance Testing – Clinical 2 ~3 }. U$ }" |
Other : X$ h; ~9 g: [. w3 m* x; r" G* l
通常"Other"不需要放, 所以是20個章節.
3 L! L5 g5 Z& S2 T# \2 ZGuidance裡有提到, 若有不適用的章節, 格式還是得留下, 然後加註"This chapter is not applicable"就行了. |
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发表于 2008-10-24 13:25
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