During the month of August, FDA conducted a nationwide 510(K) Pathway Med-tech Industry Survey to measure perceptions of 510(k) Pathway, FDA’s performance, and FDA’s consistency. Nearly 200 of the 2707 people it was sent to responded to the survey, providing a 6.1% response rate. FDA found that the majority of devicemakers are dissatisfied with the way CDRH handles 510(K) submissions. Click here to find a related article pertaining to the survey. Another related article can be found here. Need help with your 510(k) devices? Contact Pearl at email@example.com or call us at 317.899.9341
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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