Accelerating approvals of new medical devices

The US Food and Drug Administration (FDA) is looking for some help from the medical device industry in the hopes of eventually creating a process of faster, more efficient and more predictable approvals.

Background
Regulators have long been interested in making sure that tools and measures used during the medical device development process are validated – that is, proper for use and fit for purpose within a specific context. Many clinical trials are ultimately scrapped or panned by regulators when it is determined that a measurement tool does not take into account an important variable, is imprecise or is otherwise inadequate for its stated purpose.

So companies and regulators alike have a vested interest in making sure that tools – which include clinical outcome assessments (COAs), biomarker tests (BTs) and nonclinical assessment models (NAMs) – are validated, allowing both to save time and resources in the pursuit of high-quality regulatory reviews.

Read the column by Alexander Gaffney, RAC, on the Regulatory Affairs Professionals Society site.

Review the Federal Register Announcement here.