You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
Many researchers are proposing a reclassification of all hip joint metal-on-metal hips as there may exist a regulatory loop-hole allowing dangerous devices to reach patients. FDA proposed a new rule that would require these devices to submit a Premarket Approval Application (PMA) which were being accepted through the 510(k) process.
Topics: Medical Devices, Premarket Approval Application, FDA, 510(k)
With the trials IMARC Research has monitored, our experience has been that the FDA has begun inspecting clinical sites after the Sponsor submits their Premarket Approval Application (PMA), the application submitted to the FDA for approval of a Class III device. However, on one of the projects we were working on FDA contacted one of the sites for a routine inspection months before the PMA was to be submitted.
Topics: Medical Devices, Premarket Approval Application, FDA Inspection
It looks like there may be a backdoor for some companies to avoid paying the costly Medical Device User Fees. FDA published guidance at the end of May outlining how business may qualify as a “small business” under the MDUFA terms, and pay the fees at a “substantially discounted” rate.
Topics: Premarket Approval Application, FDA, Medical Device Users Fees