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.
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.