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全部话题 - 话题: subparts
1 (共1页)
s**********8
发帖数: 25265
1
来自主题: MedicalDevice版 - 21CFR820
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsear
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES PART 820 QUALITY SYSTEM REGULATION

Subpart A--General Provisions
§ 820.1 - Scope.
§ 820.3 - Definitions.
§ 820.5 - Quality system.
Subpart B--Quality System Requirements
§ 820.20 - Management responsibility.
§ 820.22 - Quality audit.
§ 820.25 - Personnel.
Subpart C--Design Con... 阅读全帖
s**********8
发帖数: 25265
2
来自主题: MedicalDevice版 - 21CFR 210 and 211
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL PART 211 CURRENT GOOD MANUFACTURING PRACTICE
FOR FINISHED PHARMACEUTICALS

Subpart A--General Provisions
§ 211.1 - Scope.
§ 211.3 - Definitions.
Subpart B--Organization and Personnel
§ 211.22 - Responsibilities of quality control unit.
§ 211.25 - Personnel qualifications.
§ 211.28 - Personnel responsibilities.
§ 211.34 - Consultants.
Subpart... 阅读全帖
l*******w
发帖数: 61
3
来自主题: Accounting版 - International tax question for experts
Here is my two cents on ASC 740 and Subpart F income.
In the simplest case, when a CFC earns $100 Subpart F income, say, an
interest income, it is a deemed dividend paid to its US parent, and the US
parent immediately made an investment of the same $100 into the sub. This
immediate reinvestment raises parent's basis in the sub by $100.
This treatment appears similar to the case where a fixed asset of parent
depreciates faster for book than for tax by $100: the book-to-tax difference
increases by... 阅读全帖
l*******w
发帖数: 61
4
来自主题: Accounting版 - International tax question for experts
Here is my two cents on ASC 740 and Subpart F income.
In the simplest case, when a CFC earns $100 Subpart F income, say, an
interest income, it is a deemed dividend paid to its US parent, and the US
parent immediately made an investment of the same $100 into the sub. This
immediate reinvestment raises parent's basis in the sub by $100.
This treatment appears similar to the case where a fixed asset of parent
depreciates faster for book than for tax by $100: the book-to-tax difference
increases by... 阅读全帖
w*****h
发帖数: 139
5
来自主题: Database版 - recursive sql?
This is a typical BOM question.
SQL99 already supports recursive SQL.
You have a table: assembly(part, subpart,...)
CREATE RECURSIVE view all_subparts(Major, Minor) AS
SELECT PART SUBPART
FROM assembly
UNION
SELECT all.Major assb.SUBPART
FROM all_subparts all, assembly assb
WHERE all.minor = assb.PART
SELECT * FROM all_subparts
b**********5
发帖数: 7881
6
来自主题: JobHunting版 - 求neflix mobile面经 大包子
今天刚面netflix, 但不是andriod or ios。 给个面经吧。 反正这里不怎么见
netfix面经
第一面: manager, 主要谈谈现在team做什么。
第二面: 一个亚裔的男, 反正是没什么口音, english first name, asian last
name的一个。 先做longest common prefix。 和leetcode一样。 然后问, 如果这
个list of inputs一个machine里装不下, 怎么办?然后我说, 反正一个machine计算
完, 就返回。一旦有subpart 的result返回来, 你就combine subpart results。
然后他问, 比如一个machine里的list特别长 compared to other machines。 然后
那个machine的longest prefix在compute的时候, 你知道是“xy。。。”, 但其他的
result, 你知道是“abc". 怎么办? 你这样等所有的subresults, 就浪费了
computing resources。 然后... 阅读全帖
g***m
发帖数: 2999
7
来自主题: _BayAreaFishing版 - 今年的 rock 季节
真的!
http://www.dfg.ca.gov/marine/mapregs5.asp#rockfish_open
Rockfish
The recreational fishery for rockfish (Sebastes sp.) is open to divers2 and shore-based anglers year-round. This fishery is closed to boat-based anglers as of January 1, 2012, and will reopen on March 1, 2012 (see important NOTE at the end of this section). These species may only be taken or possessed3 in waters less than 360 feet (60 fathoms) deep*. The daily bag and possession limit is 10 fish in combination of all species wi... 阅读全帖
s**********k
发帖数: 934
8
来自主题: _BayAreaFishing版 - 今年的 rock 季节
白高兴一场 .. 这个说的是santa babara 以南的,
"我们这"还是5月1
http://www.dfg.ca.gov/marine/mapregs4.asp

and shore-based anglers year-round. This fishery is closed to boat-based
anglers as of January 1, 2012, and will reopen on March 1, 2012 (see
important NOTE at the end of this se
approximating the 60-fathom depth contour, as defined by the set of 60-
fathom waypoints adopted in Federal regulations, 50 CFR Part 660 Subpart G.
approximating the 40-fathom depth contour, as defined by the set of 40-
fathom waypoint... 阅读全帖
t******t
发帖数: 15246
9
http://www.gsa.gov/portal/ext/public/site/FTR/file/Chapter301p0
§301-10.105 What are the basic requirements for using common carrier
transportation?
The basic requirements for using common carrier transportation fall into
three categories:
(b) Using coach-class service, unless other than coach-class service is
authorized under §301-10.123 or §301-10.162, and when travelling by ship,
using lowest first-class accommodations, unless other than lowest first-
class accommodations are authorized unde... 阅读全帖
g********d
发帖数: 4174
10
来自主题: QueerNews版 - Dharun Ravi Found Guilty in Rutgers Trial
http://news.yahoo.com/dharun-ravi-found-guilty-rutgers-trial-21
A New Jersey jury today found former Rutgers student Dharun Ravi guilty on
all counts for using a webcam to spy on his roommate, Tyler Clementi, having
a gay sexual encounter in 2010.
Ravi, 20, was convicted of invasion of privacy, bias intimidation, witness
tampering and hindering arrest, stemming from his role in activating the
webcam to peek at Clementi's date with a man in the dorm room on Sept. 19,
2010. Ravi was also convicted... 阅读全帖
a*********a
发帖数: 3656
11
来自主题: USANews版 - subject to US juristiction
这个的确是行政定义的,现在的定义在 Code of Federal Regulations (CFR), Title
31, Subtitle B, Chapter V, Part 515 , Subpart C , Section 515.329。link在下
面。
相关的是 515.329.b, Any person within the United States, 其定义在
515.330, 515.330.a.2 包括了 Any person actually within the United States。所
以当前的定义是包括非法移民的。这两条code都没有明确排出外交使节。因该是另有规
定。这个定义,多大程度上是14修划定的,并不明确。
515.329.a我的理解是公民,绿卡和公民不管人身在不在美国,都算subject to the
jurisdiction of the United States。
要排除任何非绿卡/非公民,需要修改515.330.a.2; 要排除绿卡,还需要修改515.329
.a。任何修改都有违宪的争议,会被告到法院。
但是对外国人乃至美国人,... 阅读全帖
I******e
发帖数: 6478
12
来自主题: ebiz版 - 中国人不算MINORITY吗
Minority Group [Education] Law & Legal Definition
According to 34 CFR 280.4 [Title 34 – Education; Subtitle B -- Regulations
of the Offices of the Department of Education; Chapter II -- Office of
Elementary and Secondary Education, Department of Education; Part 280 --
Magnet Schools Assistance Program; Subpart A – General], the term minority
group means the following:
“(1) American Indian or Alaskan Native. A person having origins in any of
the original peoples of North America, and who maintain... 阅读全帖
b***e
发帖数: 39
13
来自主题: JobHunting版 - International Tax Analyst position (转载)
【 以下文字转载自 Accounting 讨论区 】
发信人: babie (我是养纯种草履虫的贵族), 信区: Accounting
标 题: International Tax Analyst position
发信站: BBS 未名空间站 (Mon Dec 6 14:29:56 2010, 美东)
Our company (Archer Daniels Midland, www.adm.com) is seeking an
International Tax Analyst in the tax department. This position is open to
sponsorship at this time. Relocation and full benefit package (including
health, dental, prescription drug and life insurance, 401(k)/ESOP with
company match and pension). Please contact my mitbbs ID if you ... 阅读全帖
s******g
发帖数: 654
14
It is very complicated. State income tax should be also considered.
The tax return fee may cost you more than $5,000/year.
Subpart F income is a composite income item, consisting of the following
parts:
insurance income (see INTLOUT: 9,102);
foreign base company income, which includes the following elements: foreign
personal holding company income (see INTLOUT: 9,106), foreign base company
sales income (see INTLOUT: 9,108), foreign base company services income (see
INTLOUT: 9,110), foreign base
m*******a
发帖数: 4507
15
来自主题: Stock版 - aapl为什么发债券
跨國企業在報稅的時候是要把海外盈餘一起合併申報. 但是如果這些海外盈餘符合
Subpart F的規定 (e.g. 當地作永久性投資的用途) 則可將這些海外盈餘遞延直到盈餘
匯回美國總公司.所以APPLE雖然財報上現金, 但是真正在美國的部位並不足以支付股利
跟股票購回. 所以....
y******0
发帖数: 8807
16
来自主题: EB23版 - MD,奥本就是赌气...
上午9点40 Dahuang617 就post上VB了。然后11点要去做presentation。昨天VB肯定就
做好了,赌气不公布....
11:00 a.m. - 11:45 a.m.
The Changing Landscape at the Department of State
Several high-level changes have come to the Department of State this year.
Executive Action brought new efforts to ensure all allotted visas are
utilized and expected L-1B guidance that will affect admissions at the
consulates. The new Subpart A rule brought major changes for exchange
visitor programs. This panel will bring you up to speed on where the
... 阅读全帖
k******o
发帖数: 550
17
(c)(9) EAD 所赋予的工作许可不是如(a)(1)这样'incident to status',即使绿卡过
期了也仍然是合法的雇佣。因而485 PENDING没有EAD的雇佣仍然是非法雇佣。我想我理
解你的意思是有485 PENDING,申请EAD就好了,从实务上没有意义。不过我仍然觉得这
个案例非常的有意思,如果有人真的是在H-1B EOS同时485 PENDING,使用PENDING H-
1B工作,又没有申请EAD,EOS在485批准之后deny导致非法雇佣超过180天,究竟法理上
应该如何看待?
https://www.law.cornell.edu/cfr/text/8/274a.12 截取了部分
CFR › Title 8 › Chapter I › Subchapter B › Part 274a
› Subpart B › Section 274a.12
8 CFR 274a.12 - Classes of aliens authorized to accept employment.
§ 2... 阅读全帖
t******o
发帖数: 5314
18
And rubio's layups sometimes look like he's the chubby kid in a high school
PE class.
While i agree lin's ball handling is subpart, he could use his strength to
make up for it. He is just not doing it right now.
p********r
发帖数: 1432
19
来自主题: Pilot版 - 请教一下体检对视力的要求
See 14 CFR 61.303 for medical requirement of sport pilot.
Basically, you can use a US driver's license as medical evidence without
taking 3rd class medical check.
See subpart J of part 61 for more details about sport pilot. Remeber an article on AOPA that a guy with some sort of hear problem got his sport pilot license and started to take a long XC trip crossing all 50 states.
b*s
发帖数: 82482
20
USDA Definition and Regulations:
The Organic Foods Production Act (OFPA), enacted under Title 21 of the 1990
Farm Bill, served to establish uniform national standards for the production
and handling of foods labeled as “organic.” The Act authorized a new USDA
National Organic Program (NOP) to set national standards for the production
, handling, and processing of organically grown agricultural products. In
addition, the Program oversees mandatory certification of organic production
. The Act als... 阅读全帖
c******u
发帖数: 79
21
美国新闻版上在讨论巴马的国际税改新方案。有人担心这个方案会把美国公司赶到海外
。我参与了这个讨论,顺便进行了一下会计科普。
不过这个话题还是适合我们版讨论。我这里贴出自己的粗浅看法,抛砖引玉。
巴马的新方案包括四个方面:
第一,取消了跨国公司报税的“自选动作”(check-the-box rules)。之前,美国公
司可以把其海外子公司看作是无关实体(disregarded entities)。今后,他们必须把
海外子公司作为控股海外公司(controlled foereign corporations)来报税。也就是
说今后这些海外子公司也要依据 Subpart F之规定在美国报税。这一条可以使政府在
未来十年增收870亿。
第二,延迟海外费用的可减部分,直到海外收入报入美国收入。以前,美国公司的合规
的海外费用可以提前用来减扣在美国的可税收入,而海外费用所带来的收入可以延迟入
账。但是海外产生的研发费用还可以提前减扣美国的可税收入。这一条可使政府在未来
1年增收600亿。
第三,改革the foreign tax credit rules。包括限制cross-crediting 和
b***e
发帖数: 39
22
来自主题: Accounting版 - Opening: International Tax Analyst position
Please contact my mitbbs ID if you are interested.
Our company (Archer Daniels Midland, www.adm.com) is seeking an
International Tax Analyst in the tax department. This position is open to
sponsorship at this time. Relocation and full benefit package (including
health, dental, prescription drug and life insurance, 401(k)/ESOP with
company match and pension).
Every day, the 29,000 people of Archer Daniels Midland Company (NYSE: ADM) turn crops into renewable products that meet the demands of a gr... 阅读全帖
b***e
发帖数: 39
23
来自主题: Accounting版 - Opening: International Tax Analyst position
Please contact my mitbbs ID if you are interested.
Our company (Archer Daniels Midland, www.adm.com) is seeking an
International Tax Analyst in the tax department. This position is open to
sponsorship at this time. Relocation and full benefit package (including
health, dental, prescription drug and life insurance, 401(k)/ESOP with
company match and pension).
Every day, the 29,000 people of Archer Daniels Midland Company (NYSE: ADM) turn crops into renewable products that meet the demands of a gr... 阅读全帖
z****y
发帖数: 529
24
来自主题: Accounting版 - 南加Big 4 International Tax Group招人
我们组现在需要Associate, Senior Associate level的员工,地点是南加州。
经验方面,希望是做过一些简单的5471/8858/8865, subpart F/FTC calc的, 有基本的
subchapter C knowledge. 如果没有international tax experience的,最好有一些
federal tax experience (including FAS 109), 有research经验, 有较强的写作能力

Prefer有其他big 4经验的,或者national firm也行。CPA or LLM都可以。办H1B/绿卡
(等候时间不详)。符合条件的同学请站内联系。谢谢。
z****y
发帖数: 529
25
来自主题: Accounting版 - 南加Big 4 International Tax Group招人
投条的同学们我已经一一回复了。要是大家有认识的朋友或者同学也欢迎踊跃介绍。
简单介绍一下,我们组大约是40% consulting (cross border M&A, restructuring,
subpart F, FTC, inbound issues, etc), 30% provision (FAS 109/FIN 48), 30%
compliance (5471/8858/8865/1118/926/etc),都是做international tax方面的。
k***u
发帖数: 913
26
来自主题: Accounting版 - 上市公司的10-K report为什么叫10-K呢
just google~
SEC Form 10-K refers to the annual report pursuant to section 13 of the
Securities Act and section 15(d) of the Securities Exchange Act.
The names of these forms originated in regulations adopted by the SEC for
forms which are required for different purposes. We have attached the link
to a list of all the SEC forms. The
For example, the designation "10-K" is the form name which is designated in
17 CFR 249.310 (linked below), which provides:
===== BEGIN =====
TITLE 17 -- COMMODITY AN... 阅读全帖
k***u
发帖数: 913
27
来自主题: Accounting版 - 上市公司的10-K report为什么叫10-K呢
just google~
SEC Form 10-K refers to the annual report pursuant to section 13 of the
Securities Act and section 15(d) of the Securities Exchange Act.
The names of these forms originated in regulations adopted by the SEC for
forms which are required for different purposes. We have attached the link
to a list of all the SEC forms. The
For example, the designation "10-K" is the form name which is designated in
17 CFR 249.310 (linked below), which provides:
===== BEGIN =====
TITLE 17 -- COMMODITY AN... 阅读全帖
z****y
发帖数: 529
28
来自主题: Accounting版 - International tax question for experts
No, you don't get a DRD for dividend distribution from a CFC. Section 965
temporary DRD has expired long time ago.
Broadly, there are several things you need to consider when you receive an
actual dividend distribution from the CFC (note that this applies to an
ACTUAL distribution, rather than a DEEMED distribution such as subpart F or
section 956 income).
1. Go to Schedule J (the E&P schedule) of the prior year form 5471 and see
if there is any previously taxed income ("PTI", i.e., section 9... 阅读全帖
z****y
发帖数: 529
29
来自主题: Accounting版 - International tax question for experts
No, you don't get a DRD for dividend distribution from a CFC. Section 965
temporary DRD has expired long time ago.
Broadly, there are several things you need to consider when you receive an
actual dividend distribution from the CFC (note that this applies to an
ACTUAL distribution, rather than a DEEMED distribution such as subpart F or
section 956 income).
1. Go to Schedule J (the E&P schedule) of the prior year form 5471 and see
if there is any previously taxed income ("PTI", i.e., section 9... 阅读全帖
D*********h
发帖数: 209
30
来自主题: Accounting版 - International tax question for experts
Thanks for the insight.
One more question on international tax. What is Subpart F income's impact on
ASC 740?
Here is what I think: Sub F income is taxed without actually repatriation of
income. So this creates a temporary difference and a DTA.
Further, curreny year year Sub F income is limited to CY E&P. The excess Sub
F over CY E&P is deferred until future E&P generation.This deferred Sub F
income will also create a temp difference and a DTL.
Am I understanding this correctly? Please advise ... 阅读全帖
s********4
发帖数: 20
31
来自主题: Accounting版 - International tax question for experts
I am not in international tax, but from what I know:
1. No, the current year SubF inclusion is a perm item and therefore a rate
driver for ETR.
2. Your understanding is right - it creates a DTL for the deferred subpart F
(section 952c limitation) but your current tax expense from Sub F inclusion
is reduced by CY E&P limitation, so overall the ETR rate stays same as if
there were no E&P limitation).
Hope it helps.

on
of
Sub
D*********h
发帖数: 209
32
来自主题: Accounting版 - International tax question for experts
Thanks for the insight.
One more question on international tax. What is Subpart F income's impact on
ASC 740?
Here is what I think: Sub F income is taxed without actually repatriation of
income. So this creates a temporary difference and a DTA.
Further, curreny year year Sub F income is limited to CY E&P. The excess Sub
F over CY E&P is deferred until future E&P generation.This deferred Sub F
income will also create a temp difference and a DTL.
Am I understanding this correctly? Please advise ... 阅读全帖
s********4
发帖数: 20
33
来自主题: Accounting版 - International tax question for experts
I am not in international tax, but from what I know:
1. No, the current year SubF inclusion is a perm item and therefore a rate
driver for ETR.
2. Your understanding is right - it creates a DTL for the deferred subpart F
(section 952c limitation) but your current tax expense from Sub F inclusion
is reduced by CY E&P limitation, so overall the ETR rate stays same as if
there were no E&P limitation).
Hope it helps.

on
of
Sub
D*********h
发帖数: 209
34
来自主题: Accounting版 - International tax question for experts
just finished a rotation at my company doing year end provision calculation.
We take the indefinitely reinvestment position as well on APB 23, so
subpart F, 956 inclusion, and section 78 gross up are all perm add backs (
unfavorable adjustments) on schedule m-3. Thanks for the explanation.
When you guys do ETR reconciliation , how small of difference is ok to stop
reconciling? I was doing a company, it had about 200 mil in pretax book
income, and about 80 mil income tax expense, I manually recon... 阅读全帖
D*********h
发帖数: 209
35
来自主题: Accounting版 - what does international tax accountant do?
Mostly Subpart F analysis and FTC calculation. Both are very complicated.
GOod luck
D*********h
发帖数: 209
36
My company is treating the unrealized gain on 3rd party interest bearing
bank deposit in non functional currency as Subpart F income. Can anyone
share experience on FX g/l on bank deposit? I don't understand how can
UNREALIZED gain be taxed? Thanks
D*********h
发帖数: 209
37
Sorry about my lack of explanation. So let's say a USCo is a US C-Corp.
USCo wholy owns a Chinese company,CHCo, which is a CFC. CHCo's functional
currency is RMB.Therefore, the CHCo financial statement is kept in RMB. CHCo
for operating purpose has USD deposited in a checking account in China.
Therefore the USD the CHCo is holding is a nonfunctional currency. Under
SFAS 159 or whatever local chinese/IFRS accounting rule the USD bank deposit
is marked to market periodically. So if USD appreciate ... 阅读全帖
D*********h
发帖数: 209
38
A CFC with a nonfuntional currency bank deposit which incurred unrealized
gain should be treated as Subpart F? that's the question
D*********h
发帖数: 209
39
来自主题: Accounting版 - Transfer Pricing和International tax哪个难
Transfer Pricing and International Tax both operate in a multi-tax
jurisdiction environment.
Transfer Pricing has little to do with tax law, the only tax code TP
analysts need to deal with is IRC 482 which basically says when you have
intercompany transaction, the intercompany mark-up must be set as if it's an
arm's length transaction. This simple rule sets up the nature of TP which
is heavy in economics analysis. Naturally, most TP analysts have economics
background. Most of the analysis deal w... 阅读全帖
D*********h
发帖数: 209
40
来自主题: Accounting版 - Transfer Pricing和International tax哪个难
Transfer Pricing and International Tax both operate in a multi-tax
jurisdiction environment.
Transfer Pricing has little to do with tax law, the only tax code TP
analysts need to deal with is IRC 482 which basically says when you have
intercompany transaction, the intercompany mark-up must be set as if it's an
arm's length transaction. This simple rule sets up the nature of TP which
is heavy in economics analysis. Naturally, most TP analysts have economics
background. Most of the analysis deal w... 阅读全帖
k*******d
发帖数: 516
41
international tax一切的一切就是为了把利润留在海外,而这一切的一切的根源是美
国税35%太高。
如果降到20%,企业就失去了把前留在海外的动机,那么subpart F,FTC这些东西就都
失去了意义。
那么international tax的人工作就是去了价值,怎么办?
r*****j
发帖数: 7481
42
来自主题: CivilEngineering版 - pipeline design都是用什么标准?
最近跟一个同学聊天,他去澳洲的一个石油公司做了pipeline engineer (PHD的岩土
方向),到这个月应该做了有1年了吧。土木读了这么久,还真的没接触过pipeline
design。他们做海洋石油的,都是API和ISO code subpart C-pipeline design. 除了
这些,美国有自己的标准吗?
m********s
发帖数: 74
43
来自主题: Law版 - Re: LLM找工作经验谈(下)
thank you for your info, very informative. Hopfully you can come and share
your lawyer experience later on, good luck.

I
Subpart
No
谢.
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发帖数: 25265
44
来自主题: MedicalDevice版 - 学术第一贴 - 美国器械分类.
510K
Premarket Notification (510k)
Introduction
What is Substantial Equivalence
Who is Required to Submit a 510(k)
When a 510(k) is Required
When a 510(k) is not Required
Third Party Review Program
Introduction
Each person who wants to market in the U.S., a Class I, II, and III device
intended for human use, for which a Premarket Approval (PMA) is not required
, must submit a 510(k) to FDA unless the device is exempt from 510(k)
requirements of the Federal Food, Drug, and Cosmetic Act (the Act) ... 阅读全帖
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发帖数: 25265
45
来自主题: MedicalDevice版 - Institutional review board
An institutional review board (IRB), also known as an independent ethics
committee (IEC) or ethical review board (ERB), is a committee that has been
formally designated to approve, monitor, and review biomedical and
behavioral research involving humans with the aim to protect the rights and
welfare of the research subjects. In the United States, the Food and Drug
Administration (FDA) and Department of Health and Human Services (
specifically Office for Human Research Protections) regulations hav... 阅读全帖
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发帖数: 25265
46
来自主题: MedicalDevice版 - key device GMP component - design control
Design Controls
INTRODUCTION
Coverage
QUALITY SYSTEM
Personnel Training
DESIGN AND DEVELOPMENT PLANNING
Interface
Structure of Plans
DESIGN INPUT
Input Checklists
DESIGN REVIEW
Combination Devices
Preparation For Reviews
Why Design Reviews
Types Of Design Review Meetings
Design Review Requirements
End Of Initial Design
DESIGN OUTPUT
Documenting Design Output
Acceptance Criteria
Design Output Approval
DESIGN VERIFICATION AND VA... 阅读全帖
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发帖数: 884
47
来自主题: MedicalDevice版 - 美国进口医疗器械程序: basics
Source:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/I
Importing into the U.S.
Please note: as of October 1, 2002, FDA charges fees for review of Premarket
Notification 510(k)s and Premarket Approvals
Overview
Foreign firms that manufacture medical devices and/or products that emit
radiation that are imported into the United States must comply with
applicable U.S. regulations before, during, and after importing into the U.S
. or its territories. In order to import medical device... 阅读全帖
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发帖数: 25265
48
来自主题: MedicalDevice版 - Humanitarian Use Devices (HUD)
DEFINITIONS:
I. HUMANITARIAN USE DEVICE (HUD): A device that is intended to benefit
patients
by treating or diagnosing a disease or condition that affects fewer than 4,
000
individuals in the United States per year.
II. HUMANITARIAN USE DEVICE EXEMPTION (HDE): Food and Drug Administration
(FDA) approval of an HDE permits the marketing of an HUD, subject to
restrictions
on charges and use. Specifically, HUDs cannot be sold for profit, except in
the
limited circumstance when indicated for use in c... 阅读全帖
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发帖数: 25265
49
来自主题: MedicalDevice版 - Is Statistician needed in Medical Device Company?
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 820 -- QUALITY SYSTEM REGULATION
Subpart O--Statistical Techniques
Sec. 820.250 Statistical techniques.
(a) Where appropriate, each manufacturer shall establish and maintain
procedures for identifying valid statistical techniques required for
establishing, controlling, and verifying the acceptability of process
capability and product characteristics.
(b) Sa... 阅读全帖
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发帖数: 25265
50
来自主题: MedicalDevice版 - 问题请教: Design control process
CFR 820 subpart C.
for quality, safety and design under defined criteria.
1 (共1页)