In its February 25 interview with Sarah Chandler (A/Head, Regulatory and Scientific Section, Device Licensing Services Division, Medical Devices Bureau), ComplianceAcuity confirmed that the Bureau has seen a significant increase in the volume and complexity of device license applications during the last 12-18 months.
As the Bureau grapples with the influx, the processing of Class III and IV non-IVDD device applications are taking approximately 60-days longer than the Bureau’s post-screening 60-day (class III) and 75-day (class IV) review targets in the Musculoskeletal and the General & Restorative device license evaluation Sections. The Cardiovascular Section has experienced similar backlogs recently, however is “on target” at the moment. Applications for IVDD’s are taking 6-8 months.
ComplianceAcuity has also learned that class II device license applications are taking approximately three weeks (versus the Bureau’s 15-day policy target). Fax-back amendments are on schedule.