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Q of the week

Q: Do clinical trials ever go wrong?

Get the Answer: 

Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

21 CFR PART 820

 

o Presentation: Quality System Regulation 21 CFR 820 - Basic Introduction

 

European Medical Device Regulations

 

o European Medical Device Regulations

o Regulation of Medical Devices in the United States and European Union

o Guidance MEDDEVs

 

510 K Submissions

 

o 510(k) Submission Process

o The US FDA 510(k) Submission Process

o 510(k) Submission Methods

o 510(k) Clearances

o Premarket Notification (510k)

 

PMA Submissions

 

o PMA Approvals

o Submission Services

o Pharmaceutical Industry: Post Marketing Authorisation Approval

o Post-Marketing Authorisation: Regulatory and Procedural Guidance

 

Australia

 

http://www.tga.gov.au/industry/devices.htm

 

China

 

http://eng.sfda.gov.cn/WS03/CL0759/

 

India

 

http://cdsco.nic.in/google/FRONT%20PAGE%20A.html

 

Japan

 

http://www.pmda.go.jp/english/service/regulation.html

 

Malaysia

 

http://www.mdb.gov.my/mdb/

 

NewZealand

 

http://www.medsafe.govt.nz/devices/devices-landing.asp

 

Singapore

 

http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/medical_devices.html

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Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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