In its September 7 interview with Sarah Chandler (A/Head, Regulatory and Scientific Section, Device Licensing Services Division, Medical Devices Bureau), ComplianceAcuity confirmed that the Bureau is still wrestling with 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 30-days longer than the Bureau’s post-screening 60-day (class III) and 75-day (class IV) review targets in the Cardiovascular and Musculoskeletal device license evaluation Sections. The General & Restorative Section is 3 weeks behind schedule. Applications for IVDD’s are taking 1-2 weeks longer than review targets.
ComplianceAcuity has also learned that class II device license applications are taking approximately three and a half weeks (versus the Bureau’s 15-day policy target). Fax-back amendments are on schedule.