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A newsletter for those involved in clinical trials. Published 20 times a
year by Canary LtdMedical devices
The following articles on this topic have been published in
CRAdvisor (CRA) – the year, issue number
and starting page number for each are listed below:
Back to index |
| 2007 |
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CRA 2007; 195:5 |
Florida-based sponsor violates device regulations. |
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| 2006 |
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| CRA 2006; 163:11 |
India reclassifies devices as drugs. |
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CRA 2006; 166:7 |
FDA and AdvaMed Workshops on Postmarket Safety of Devices. |
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CRA 2006; 174:2 |
New arrangements for the ethics committee review of device studies. |
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| 2005 |
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| CRA 2005; 143:5 |
Recent FDA inspections lead to more investigators
receiving warning letters. |
| CRA 2005; 144:7 |
Japan will require third-party accreditation of low-risk
devices. |
| CRA 2005; 148:3 |
Violation of consent puts patients at risk. |
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| 2004 |
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| CRA 2004; 123:3 |
Improving best practices: FDA warnings to sponsors reveal
significant defects. |
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| 2003 |
|
| CRA 2003; 102:8 |
Devices could face drug regulation compliance. |
| CRA 2003; 109:6 |
Singapore launches new standards for medical devices. |
| CRA 2003; 116:6 |
FDA draft guidance on pre-market assessment of paediatric
medical devices. |
| CRA 2003; 117:4 |
European guidance on the evaluation of clinical data on
medical devices. |
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| 2002 |
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| CRA 2002; 83:6 |
Medical devices to meet the EC Product Safety Directive. |
| CRA 2002; 84:6 |
EU meeting considers devices. |
| CRA 2002; 95:6 |
ISO Technical Committee to finalise clinical trial
standards for medical devices. |
| CRA 2002; 100:6 |
An overview of US regulations contained in the Code of
Federal Regulations. |
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| 2001 |
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| CRA 2001; 67:3 |
New ISO standard for device trials. |
| CRA 2001; 73:6 |
Devices: FDA gets tough on violators. |
| CRA 2001; 76:4 |
Device trials under scrutiny. |
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| 2000 |
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| CRA 2000; 51:5 |
US regulations vary for medical device trials. |
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| 1999 |
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| CRA 1999; 34:4 |
EN540 responsibilities for device studies. |
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| 1998 |
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| CRA 1998; 6:5 |
Monitoring trials on devices. |
| CRA 1998; 11:4 |
Device study violates FDA requirements. |