The U.S. Food and Drug Administration (FDA) is in part responsible for ensuring the public has access to safe and effective medical products. This responsibility includes enforcing regulations covering medical devices and radiation-emitting products.
Per the FDA, their “oversight of devices is risk-based, which means that the level of regulatory controls necessary to demonstrate a reasonable assurance of safety and effectiveness is typically matched to the level of risk of the device.” Thus, the FDA has established pre-market pathways for medical device approvals based on the device’s associated risk level. Understanding the following FDA pre-market pathways is important to medical device manufacturers’ success in commercializing their medical devices:
High risk devices (Class III) – Premarket Approval (PMA) is required
Moderate risk (Class II) devices and some low risk (Class I) devices
De Novo Classification Request – required when there is no legally marketed predicate device
Premarket Notification 510(k) – required when there is a legally marketed predicate device
Most low risk (Class I) devices and some moderate risk (Class II) devices
No FDA pre-market review is necessary
OnemataDC’s team has extensive experience successfully guiding companies through the FDA’s clearance and approval processes with hundreds of approved and cleared devices in the marketplace today. You can lean on OnemataDC to successfully navigate the FDA pre-market review process, as well as the numerous exceptions and nuances to medical device regulations and pre-market pathways.
If you have questions about these processes, need a fresh perspective, or would like proactive guidance, please reach out to speak with a team member.