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发帖数: 25265 | 1 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 |
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发帖数: 25265 | 2 CDER and CDRH share responsiblities when combo products are concerned.
emit |
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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 |
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发帖数: 884 | 4 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 |
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发帖数: 2823 | 5 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 |
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发帖数: 25265 | 6 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 |
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发帖数: 25265 | 7 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 |
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发帖数: 25265 | 8 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 | 9 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 |
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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 |
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发帖数: 961 | 11 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 |
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发帖数: 5516 | 13 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 |
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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 |
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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 |
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c******d
发帖数: 564 | 18 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 |
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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。 |
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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 |
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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 |
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发帖数: 266 | 25 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 |
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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. |
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e****t
发帖数: 971 | 30 thanks for sharing
learn |
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发帖数: 4884 | 31 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. |
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发帖数: 201 | 32 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 |
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发帖数: 25265 | 33 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. |
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发帖数: 25265 | 34 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. |
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发帖数: 25265 | 35 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 |
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发帖数: 2059 | 42 hmmm... interesting...haha... |
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发帖数: 25265 | 43 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 |
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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 |
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发帖数: 25265 | 45 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 |
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发帖数: 25265 | 46 .....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 |
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发帖数: 884 | 47 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: 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 |
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发帖数: 25265 | 49 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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