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USA: CDRH drafts Guidance on Contact …
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) release…
FDA Drafts Guidance for Regulatory Su…
The US Food and Drug Administration (FDA) issued draft guidance providing recommendations on an alter…
FDA Bans Electrical Stimulation Devic…
The US Food and Drug Administration (FDA) announced to ban electrical stimulation devices (ESDs) used…
Medical Device Incident and Adverse E…
Prior preparation is necessary for an immediate investigation of incidents once they occur. This is n…
USA and EUROPE Looking Ahead to 2020
USA – Food and Drug Administration (FDA)
The Center for Drug Evaluation and Research (CDER) contin…
TGA: Regulatory Impact Statement R…
Technology changes have the potential to deliver significant advantages and opportunities to Australi…
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