GMP News - Medical Devices


FDA publishes Draft Guidance on Clinical Studies for Medical Devices

At the end of 2011, the FDA published two draft guidance documents on clinical studies for medical devices. More about the content and the pilot programme started in this context can be found here.



FDA Compliance Programme Guidance on Inspections of Medical Devices Manufacturers

Medical device manufacturers "fear" FDA inspections as well. Companies which have never had an FDA inspection often don't know how such an inspection is performed. They can find support in an FDA Manual published last year.



New FDA Online Training on GMP for Medical Devices

What are FDA's requirements regarding medical devices? The FDA itself gives a partial answer to this question. At the end of last year and at the beginning of this year, the FDA has been making an extensive update of its online training available on CDRH's (Center for Devices and Radiological Health) medical devices homepage. Read more here.



Medical Devices: European Commission calls for Immediate Actions - Tighten Controls, Increase Surveillance

The European Commission has published a press release from the Commissioner for Health and Consumer Policy. This press release is entitled "Medical devices: European Commission calls for immediate actions - tighten controls, increase surveillance, restore confidence". Read more here.



GMP for Medical Devices - Lessons learnt from the PIP Scandal?

The scandal of falsified breast implants is making waves. This could result in changes in the current medical devices regulations. Guideline drafts are expected shortly. Read more here.


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