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US FDA pilot aims for 30-day review of 510(k)s submissions for IVDs, radiology devices

 
• By Vibha Sharma

The US Food and Drug Administration has launched a six-month pilot programme under which it will aim to issue decisions on certain "good quality" pre-market notification (510(k)) submissions within 30 days, rather than its current standard of 90 days1.

The US Food and Drug Administration has launched a six-month pilot programme under which it will aim to issue decisions on certain "good quality" pre-market notification (510(k)) submissions within 30 days, rather than its current standard of 90 days1.

The pilot programme, called Triage, will apply to traditional 510(k) applications (not special or abbreviated 510(k)s) for certain in vitro diagnostic and radiology products

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• By Ashley Yeo

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• By Brian Bossetta

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