The year 2018 was a record year at the Food and Drug Administration (FDA) for medical device approvals and clearances. The agency issued 54 Premarket Approvals (PMA), 44 De Novo classifications, and 3,022 510(k) marketing clearances in 2018, according to the FDA Medical Device Databases. This represents a continuing upward trend for new devices that gain marketing clearance via the PMA and de novo regulatory pathways.
Three pathways to review
Medical devices are reviewed by the FDA via one of three regulatory pathways; these regulatory pathways differ in the level of evidence required to demonstrate efficacy and safety. High-risk devices are reviewed via the PMA process, which requires substantial clinical evidence demonstrating reasonable assurance that a device is safe and effective.
In contrast, low- to moderate-risk devices are reviewed via the 510(k) notification system, which merely requires demonstrating substantial equivalence to a predicate device already on the market. For devices without a predicate, the de novo process represents a less burdensome review process for devices that are ineligible for 510(k) review but are not high risk.
Modernizing the approach
The FDA recently finalized guidance establishing the framework for the Safety and Performance Based Pathway, a new approach to 510(k) clearance. This framework is intended to modernize the regulatory approach to moderate-risk devices by allowing manufacturers to use objective performance criteria to facilitate demonstration of substantial equivalence of new products to legally marketed devices.
The benefit of this approach is that the pathway will benchmark modern technology against modern standards while offering a potentially more efficient way to demonstrate that a new device is substantially equivalent to devices already on the market. This will allow patients to have timely access to beneficial products.
Given that there are multiple pathways to market for medical devices in the U.S., determining whether the level of evidence supporting marketing clearance also supports clinical adoption and payer coverage can be challenging. TractManager is committed to helping our customers address this challenge.
Hayes Horizon Scanning meets the challenge
The TractManager/Hayes Horizon Scanning team monitors novel medical devices that have recently been granted marketing approval or clearance by the FDA, as well as devices that are likely to enter the market in the future. We provide customers with timely, critical information they need to make decisions about new technologies on the near horizon.
Our solutions provide answers to key questions:
- What is the unmet need being addressed by the new device?
- Where is the technology in the regulatory cycle? Is regulatory clearance imminent?
- When will the technology enter the market?
- What is the current state of clinical evidence?
Since the multiple pathways to regulatory clearance require varying levels of evidence, it’s critical for healthcare providers and stakeholders to have a clear understanding of the evidence supporting new technologies in order to make informed decisions about patient care. Hayes Horizon Scanning provides that critical early analysis of evolving evidence supporting emerging technologies.