CBSA’s BioBreakfast on Wednesday discussed the FDA approval process from a Medical Device Perspective. The panel discussion focused on the changing rules and attitudes that could affect medical device approval moving forward. Panelists at the event were:
- Mark Holmes, CaridianBCT, VP of Regulatory and Government Affairs
- Keith Martin, Medtronic Navigation, Senior Director Quality Systems and Regulatory Affairs
- Deborah Arthur, Cochlear Americas, Vice-President Regulatory and Quality
The panel first concentrated on the changes that might come to Class 2 devices that are cleared for marketing based on the less stringent 510k approval process. Devices that are approved via 510k are done so based on substantial equivalence to a predicate technology. Holmes commented that the FDA may be granted recision authority over 510k approved devices. Arthur noted the potential uncertainty for many devices if the predicate device from their 510k was rescinded.
To class 3 devices cleared approved with a PMA, the panel focused more post marketing issues. There is a general belief the FDA is becoming more risk adverse both in approvals and in decision surrounding post-market inspections. Martin commented that when companies take action to mitigate risk with an approved product, the FDA seems to pushing towards recalls even when this extreme action may not be necessary.
The experience panel also offered thoughts to help small companies beginning the FDA process. Holmes stated that “any approval is a judgment call” and as such companies must focus not only on having quality data but also presenting it in a clear and well-written way. Arthur commented that it may make sense to seek approval in other countries first – notably Europe or Canada – as the regulatory path there is somewhat clearer.
