The special 510(k) submission process was introduced in the late 1990’s as part of the FDA’s initiative to provide alternative approaches to the traditional 510(k) clearance route, while simultaneously reducing regulatory burdens and review times. Over time, the scope of special 510(k) use and the FDA’s methodology on reviewing such submissions has shifted, particularly under the FDA’s Refuse to Accept (RTA) policy enacted in 2013. While the FDA hasn’t released any new or updated guidance regarding special 510(k)s, industry regulators are stymied as to what the best approach may be for modified devices which have been previously obtained 510(k) clearance.
- Understanding FDA’s application of requirements
- Trends in use and approval of special 510(k)s
- Requirements for declaring conformance
- Approval time frames
- Rejected submissions
- Defining ideal circumstances for a special 510(k) submission
- Forecasting future develops and impacts on industry