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s**********8
发帖数: 25265
1
来自主题: MedicalDevice版 - 学术第二贴 - CDRH
Center for Devices and Radiological Health
From Wikipedia, the free encyclopedia
Jump to: navigation, search
The Center for Devices and Radiological Health (CDRH) is the branch of the
United States Food and Drug Administration (FDA) responsible for the
premarket approval of all medical devices, as well as overseeing the
manufacturing, performance and safety of these devices. The CDRH also
oversees the radiation safety performance of non-medical devices which emit
certain types of electromagnetic... 阅读全帖
s**********8
发帖数: 25265
2
来自主题: MedicalDevice版 - 学术第二贴 - CDRH
CDER and CDRH share responsiblities when combo products are concerned.

emit
s**********8
发帖数: 25265
3
来自主题: MedicalDevice版 - FDA
The Food and Drug Administration (FDA or USFDA) is an agency of the United
States Department of Health and Human Services, one of the United States
federal executive departments. The FDA is responsible for protecting and
promoting public health through the regulation and supervision of food
safety, tobacco products, dietary supplements, prescription and over-the-
counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals,
blood transfusions, medical devices, electromagnetic radiati... 阅读全帖
s*********e
发帖数: 884
4
来自主题: MedicalDevice版 - the Medical Device Innovation Initiative by FDA
Source:
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHInnovation/
What is the Medical Device Innovation Initiative?
The CDRH Medical Device Innovation Initiative proposes actions that CDRH
could take to help accelerate and reduce the cost of development and
regulatory evaluation of innovative medical devices safely and based on
sound science.
How will the Medical Device Innovation Initiative promote and support
investment in new technology?
Lack of a transparent, predictable path to marke... 阅读全帖
h********e
发帖数: 2823
5
来自主题: MedicalDevice版 - How to market a medical device, by FDA
Source:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/H
How to Market Your Device
Please note: as of October 1, 2002, FDA charges fees for review of Premarket
Notification 510(k)s and Premarket Approvals
Introduction
Three Steps to Obtaining Marketing Clearance from CDRH
Classify Your Device
Selecting the Appropriate Marketing Application
Other Requirements Besides Marketing Clearance
In Vitro Diagnostic Devices
Introduction
One of the most difficult aspects of getting a medical... 阅读全帖
s**********8
发帖数: 25265
6
来自主题: MedicalDevice版 - FDA Modernization Act of 1997
Overview of FDA Modernization Act of 1997, Medical Device Provisions
CDRH FDA Modernization Act of 1997 Page1
Foreword
Preface
Introduction
Investigational Device Exemptions
Premarket Approval
Premarket Notification [510(k)]
Device Classification
Device Labeling
Device Tracking
Postmarketing Surveillance
Global Harmonization
Medical Device Reporting and Recall Reports
Establishment Registration
Device Standards
Other Sections Related to Medical Devices
Foreword
The Center for Devices and Radiolo... 阅读全帖
s**********8
发帖数: 25265
7
来自主题: MedicalDevice版 - FDA Regulation of Medical Devices
http://www.qrasupport.com/FDA_MED_DEVICE.html
Overview: FDA Regulation of Medical Devices
The following information is provided as general guidance to the Food and
Drug Administration (FDA) regulation of medical devices. The Center for
Devices and Radiological Health (CDRH) is the division of FDA responsible
for medical device regulation. CDRH maintains a very informative web site.
The CDRH web site is located at: http://www.fda.gov/cdrh/devadvice/default.htm.
For support in working with the FDA... 阅读全帖
s**********8
发帖数: 25265
8
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
s**********8
发帖数: 25265
9
来自主题: MedicalDevice版 - 学术第一贴 - 美国器械分类.
PMA
Premarket Approval (PMA)

Please note: As of October 1, 2002, FDA charges a fee for review of
Premarket Approvals1
Overview
When a PMA is Required
Devices Used in Blood Establishments
Data Requirements
References
Overview
Premarket approval (PMA) is the FDA process of scientific and regulatory
review to evaluate the safety and effectiveness of Class III medical devices
. Class III devices are those that support or sustain human life, are of
substantial importance in preventing impairment of... 阅读全帖
a*i
发帖数: 1652
10
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/searc
MAUDE data represents reports of adverse events involving medical devices.
The data consists of voluntary reports since June 1993, user facility
reports since 1991, distributor reports since 1993, and manufacturer reports
since August 1996. MAUDE may not include reports made according to
exemptions, variances, or alternative reporting requirements granted under
21 CFR 803.19.
The on-line search allows you to search CDRH database inf... 阅读全帖
y*****3
发帖数: 961
11
来自主题: MedicalDevice版 - FDA Reviewers Get New Training
IMARC Research - Friday, September 16, 2011
On September 6th, the FDA announced two new training programs designed to
improve the consistency of medical device reviews by enhancing the skills of
those reviewing premarket applications at the Center for Devices and
Radiological Health (CDRH).The 18-month training program will apply to all
new device reviewers from the CDRH’s anesthesia, general hospital,
infection control and dental devices divisions.Dr. Jeffrey Shuren indicates
the investment is ... 阅读全帖
s**********8
发帖数: 25265
12
http://www.raps.org/Regulatory-Focus/News/2014/10/08/20511/FDA-Announces-Major-Regulatory-Changes-With-Specialization-a-Key-Focus/?utm_source=Email&utm_medium=Informz&utm_campaign=Weekly%2DUpdate
Regulatory functions at the US Food and Drug Administration (FDA) are set to
undergo a major overhaul in the coming months after a year-long effort by
the agency recommended making scores of improvements to the way the agency
is structured and regulates products.BackgroundIn September 2013, FDA
announce... 阅读全帖
v**********m
发帖数: 5516
13
来自主题: _pennystock版 - Alxa的汇总
An Update on Alexza Pharma (ALXA) - Analyst Blog
By Zacks
Jason Napodano, CFA
On October 10, 2010, the U.S. FDA issued a complete response letter (CRL) on
the approval of AZ-004 (Staccato loxapine) for the rapid treatment of
agitation in patients with schizophrenia or bipolar disorder. The FDA
raised four issues in the CRL with the new drug application for Adusuve:
1) The FDA raised concern on the clinical safety data from the three phase I
pulmonary safety studies with AZ-004 based on observed... 阅读全帖
z*****s
发帖数: 289
14
这是GLP的连接
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsear
你找找到一条对具体实验设计和创新有约束?

验,
t******e
发帖数: 2504
15
美国产大米砷含量FDA检测结果如下link:
http://www.fda.gov/downloads/Food/FoodborneIllnessContaminants/Metals/UCM352467.pdf
单位是mcg(微克)/serving, 根据FDA的规定:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=101.12
大米每个serving=45g干品, 中国定的标准是150微克/1000g大米干品,折算成mcg/
serving是6.75。
浏览一下,基本结论是:
按品种:
basmiti米: 美国产和印巴产砷含量基本上在中国标准以下;
香米(jasmine): 美国产和泰国产砷含量都在中国标准以下;
白米长粒(white long): 美国产砷含量基本上在中国标准以下. 个别超标。
白米中粒(white mediam):美国产砷含量都在中国标准以下;
白米短粒(white short): 美国产砷含量都在中国标准以下.
黄米(brown rice):大概有一半检测样品超... 阅读全帖
l******5
发帖数: 3030
16
Contact the recruiter directly please
Principal Research Scientist-PK/PD- Indiana -
The Principal Research Scientist functions as a project leader in a
multidisciplinary team environment with primary responsibility for the early
preclinical development of antibodies and protein molecules.
KEY OBJECTIVES/DELIVERABLES:
- Integrate pharmacokinetics and PK/PD with discovery biology to define
structure activity relationships to guide protein engineering strategies and
to help optimize development of ... 阅读全帖
c******d
发帖数: 564
17
俺自己是搞生物医学的,去年丈母娘看了这篇文章,让俺解惑一下,于是做了点功课。
这篇关于菜籽油(Canola,来源是油菜)的文章基本是一个对科学一知半解的人,断章
取义,添油加醋来的。他后面附的参考资料来源也都不可靠。文章声称
1,“食用菜籽油的人,视力,听力,排泄系统,呼吸系统,心脏,神经都除了问题”
我搜索我们常用的科研数据库“ ncbi”(美国卫生研究院生物信息中心),没有发现
报告。
菜籽油最主要的有害成分是 油菜酸(又名芥酸, Erucic acid),大量食用对心脏不
好。 但是油菜酸在菜籽油里面含量低于2%,美国药检局,欧洲都认为是安全的。欧洲
人还 用菜籽油做婴儿食品。
2,文章 暗示“ 菜籽油导致疯牛病”
事实是疯牛病的病因很独特,常规手段找不到病原,所以早期的谣言传播者就把帐算在
菜籽油头上了。现在病因已经清楚了,是结构变化的蛋白质造成的。
3,文章声称“菜籽油降低体内维生素E”
原始出處是這篇試驗報告“Effects of supplemental vitamin E and canola oil on
tissue tocopherol and liver fat... 阅读全帖
c******d
发帖数: 564
18
来自主题: NewJersey版 - 关于Canola 油
俺自己是搞生物医学的,去年丈母娘看了这篇文章,让俺解惑一下,于是做了点功课。
这篇关于菜籽油(Canola,来源是油菜)的文章基本是一个对科学一知半解的人,断章
取义,添油加醋来的。他后面附的参考资料来源也都不可靠。文章声称
1,“食用菜籽油的人,视力,听力,排泄系统,呼吸系统,心脏,神经都除了问题”
我搜索我们常用的科研数据库“ ncbi”(美国卫生研究院生物信息中心),没有发现
报告。
菜籽油最主要的有害成分是 油菜酸(又名芥酸, Erucic acid),大量食用对心脏不
好。 但是油菜酸在菜籽油里面含量低于2%,美国药检局,欧洲都认为是安全的。欧洲
人还 用菜籽油做婴儿食品。
2,文章 暗示“ 菜籽油导致疯牛病”
事实是疯牛病的病因很独特,常规手段找不到病原,所以早期的谣言传播者就把帐算在
菜籽油头上了。现在病因已经清楚了,是结构变化的蛋白质造成的。
3,文章声称“菜籽油降低体内维生素E”
原始出處是這篇試驗報告“Effects of supplemental vitamin E and canola oil on
tissue tocopherol and liver fat... 阅读全帖
h********r
发帖数: 3291
19
Thanks whatevernow pointed out the FDA page http://www.fda.gov/cdrh/ppe/masksrespirators.html
Here is a list of all current FDA approved surgical N95 mask.
http://tinyurl.com/4b485o
g*****x
发帖数: 3283
20
连azodicarbonamide是啥都不知道的人也开始谈食品安全了,真是笑死我了。
首先这玩意是FDA批准的合法的面粉添加剂,基本上所有面粉都会加
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSear
其次这玩意不致癌,去看MSDS
http://www.sciencelab.com/msds.php?msdsId=9922989
最后,欧洲国家禁用这个主要是因为粉末状固体吸入肺部可能会引发过敏和哮喘
http://en.wikipedia.org/wiki/Azodicarbonamide
n*******n
发帖数: 515
21
很全面,值得读几遍。
最后一段,因为pdufa和mdufa的原因,cdr和cdrh没有完全关门。但是由于一些非核心
部门的关闭,nda,pma和510k 的处理速度还是受到了影响。
h*******o
发帖数: 4884
22
这个只是RA的几个方面之一,相对于FDA的CDER, 勉强和CBER挂钩
和CDRH没多大联系,还有其他的
h*******o
发帖数: 4884
23
这个只是RA的几个方面之一,相对于FDA的CDER, 勉强和CBER挂钩
和CDRH没多大联系,还有其他的
i***l
发帖数: 1656
24
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/I
看到你还去制药版面问,根本不同的领域。
IVD大多数属于CDRH管,药厂不是。看看510K,不过没有经验,也是可能空口白说。
GOOGLE
j*******1
发帖数: 266
25
来自主题: ChineseMed版 - FDA临床试验不适合中药之狠狠打脸
An IND may be submitted for one or more phases of an investigation. The
clinical investigation of a previously untested drug is generally divided
into three phases. Although in general the phases are conducted sequentially
, they may overlap. These three phases of an investigation are a follows:
(a) Phase 1. (1) Phase 1 includes the initial introduction of an
investigational new drug into humans. Phase 1 studies are typically closely
monitored and may be conducted in patients or normal volunteer... 阅读全帖
l********r
发帖数: 109
26
来自主题: Pharmaceutical版 - 有人懂CMC regulatory 么?
eCTD (CMC is mainly in M2, M3 I think)
http://www.fda.gov/cder/regulatory/ersr/ectd.htm
http://www.fda.gov/cder/regulatory/ersr/5640CTOC-v1.2.pdf
If you change sth on the licensed process then you need update/inform
agencies:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=601.12
A good course for you:
http://www.ibclifesciences.com/C2025/6018.xml
c**p
发帖数: 1443
27
which center are you in?
I know at least CDER and CDRH are good for non-citizen, non-GC, not
contractor, but federal employee.
ot
发帖数: 4549
28
来自主题: Pharmaceutical版 - CDRH Learn
http://www.fda.gov/Training/CDRHLearn/ucm162015.htm#overview
基础的QA, QC教程,还不用花钱。给大家推荐一下。缺点是看着真困啊。
ot
发帖数: 4549
29
来自主题: Pharmaceutical版 - CDRH Learn
Here is the CDER Learn site for the pharm people. Can't find any CBER learn
for the biologics people.
http://www.fda.gov/Training/ForHealthProfessionals/default.htm
e****t
发帖数: 971
30
来自主题: Pharmaceutical版 - CDRH Learn
thanks for sharing

learn
h*******o
发帖数: 4884
31
来自主题: Pharmaceutical版 - FDA方法的死穴是什么?
well, somebody I knew just get their IND approved for Phase I and IIa trials
on a combinational formulation, which includes three compounds.
Also, think about drug/device combo,
none of them will likely to work if administered alone. althought a Little
bit more complicated, it is still pretty much the same process. depends on
its primary mechanisms of action, it may go to CDER or CDRH.
j********t
发帖数: 201
32
来自主题: Statistics版 - data standard for FDA submission
got your message from private box - sorry to reply late:
a few things that might be useful, but please contact your regulatory
department for the final formats:
1) even for non-cdisc compliant submission, it's useful to provide a define.
xml(use proc contents, ods tagsets.excel) and define.pdf (refers to http://www.lexjansen.com/pharmasug/2012/AD/PharmaSUG-2012-AD14.pdf).
2) limit length of variable names to 8 even SAS 9.2 or later goes beyond
that. (label length = 40).
3) make xpt files that le... 阅读全帖
s**********8
发帖数: 25265
33
来自主题: MedicalDevice版 - 什么样的医疗器械是国内没得的
SR and NSR all class III. just IDE process different. 你这个需要CDRH clear吧
. 额也不太十分清楚, 有经验的说说.
s**********8
发帖数: 25265
34
来自主题: MedicalDevice版 - 什么样的医疗器械是国内没得的
SR and NSR all class III. just IDE process different. 你这个需要CDRH clear吧
. 额也不太十分清楚, 有经验的说说.
s**********8
发帖数: 25265
35
来自主题: MedicalDevice版 - 学术第一贴 - 美国器械分类.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/O
Device Classification
Please note: as of October 1, 2002, FDA charges fees for review of Premarket
Notification 510(k)s1 and Premarket Approvals2
Classify Your Medical Device
Introduction
How To Determine Classification
Introduction
The Food and Drug Administration (FDA) has established classifications for
approximately 1,700 different generic types of devices and grouped them into
16 medical specialties referred to as panels. Each ... 阅读全帖
G*********o
发帖数: 49669
36
来自主题: MedicalDevice版 - 学术第二贴 - CDRH
看不懂
勉强re

emit
s**********8
发帖数: 25265
37
来自主题: MedicalDevice版 - 学术第二贴 - CDRH
假jj也是器械.
G*********o
发帖数: 49669
38
来自主题: MedicalDevice版 - 学术第二贴 - CDRH
嗯,你买了?

假jj也是器械.
s**********8
发帖数: 25265
39
来自主题: MedicalDevice版 - 学术第二贴 - CDRH
卖给老杨了
G*********o
发帖数: 49669
40
来自主题: MedicalDevice版 - 学术第二贴 - CDRH
老杨口味很重

卖给老杨了
s**********8
发帖数: 25265
41
来自主题: MedicalDevice版 - 学术第二贴 - CDRH
as always
m********e
发帖数: 2059
42
来自主题: MedicalDevice版 - 学术第二贴 - CDRH
hmmm... interesting...haha...
s**********8
发帖数: 25265
43
来自主题: MedicalDevice版 - Institutional review board
Frequently Asked Questions About the IRB:
The following is a compilation of questions frequently asked regarding
Institutional Review Boards, human subject protection and compliance with
federal regulations. These questions are organized according to whether they
pertain to:
I. Institutional Review Board regulations;
II. Informed Consent regulations;
III. Clinical investigations involving drugs;
IV. Clinical investigations involving medical devices; and
V. Other
I. INSTITUTIONAL REV... 阅读全帖
s**********8
发帖数: 25265
44
来自主题: MedicalDevice版 - PMA
Premarket approvalFrom Wikipedia, the free encyclopediaJump to: navigation,
search
Premarket approval (PMA) is the U.S. Food and Drug Administration (FDA)
process of scientific and regulatory review to evaluate the safety and
effectiveness of Class III medical devices and is significantly different
from the Premarket Notification process known as 510(k). Class III devices
are those that support or sustain human life, are of substantial importance
in preventing impairment of human health, or whic... 阅读全帖
s**********8
发帖数: 25265
45
来自主题: MedicalDevice版 - Federal Food, Drug, and Cosmetic Act and 510(K)
Federal Food, Drug, and Cosmetic ActFrom Wikipedia, the free encyclopedia (
Redirected from 510k)
Jump to: navigation, search
This article may require cleanup to meet Wikipedia's quality standards.
Please improve this article if you can. The talk page may contain
suggestions. (February 2011)
Federal Food, Drug, and Cosmetic Act
Acronym FFDCA, "FD&C Act"
Enacted by the 75th United States Congress
Citations
Public Law 75-717
Stat. 52 US Stat. 1040
Codification
U.S.C. sections created 21 U.S.C. §... 阅读全帖
s**********8
发帖数: 25265
46
来自主题: MedicalDevice版 - Federal Food, Drug, and Cosmetic Act and 510(K)
.....FDA regulates all health care products, dont just go with names.
CDER: center for drug evalutation and research, basically small molecule
chemical drug
CBER: center for biologics evaluation and research.
CDRH: center for devices and radigological health
s*********e
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
k****i
发帖数: 1126
48
Investigations covered under the IDE regulation are subject to differing
levels of regulatory control depending on the level of risk. The IDE
regulation distinguishes between significant and nonsignificant risk device
studies and the procedures for obtaining approval to begin the study differ
accordingly. Also, some types of studies are exempt from the IDE regulations.
Significant Risk Device
A significant risk device presents a potential for serious risk to the
health, safety, or welfare of a s... 阅读全帖
s**********8
发帖数: 25265
49
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
s**********8
发帖数: 25265
50
来自主题: MedicalDevice版 - the Medical Device Innovation Initiative by FDA
this very new.
published in Q1 of this year.
it's very good to know and i will read through.
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHInnovation/
1 (共1页)