Tentamen (uitwerkingen)
GCP OF DEVICES QUESTIONS AND ANSWERS
- Vak
- Instelling
510(k) Clearance - Answer- A 510(k) clearance or premarket notification [(510(k)] submission is a route the FDA uses to approve a medical device. If the FDA agrees the new device is substantially equivalent to a legally marketed device for which a premarket approval (PMA) is not required, the manuf...
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