Submitted by kBLASTER Team on
Posted 03 February 2015 By Alexander Gaffney, RAC for RAPS.org
An abbreviated summary of this posted article will focus on sections with issues that could impact the 510(k) clearance process:
The US Senate's Health, Education, Labor and Pensions (HELP) Committee is in the early stages of launching its own legislative process intended to help reform the ways in which the US Food and Drug Administration (FDA) regulates drugs and medical devices, it has announced.
The effort, announced on 29 January 2014, is being led by Sens. Lamar Alexander (R-TN) and Richard Burr (R-NC), and is meant to complement similar efforts by the House Energy and Commerce (E&C) Committee that are called the 21st Century Cure Act.
But if their methods are still unclear, their goal is not: Cutting down on the time it takes to bring new medical products to American patients.
"While the FDA has reviewed drugs in as little as three months, and meets the timelines set for medical device reviews the majority of the time, the inability of medical product developers to predict what questions will be asked during the review forces a multi-year process simply to get an application ready for FDA consideration," the report notes in its introduction. The growing complexity of medical products is likely to further complicate the regulatory review of those same products, the report hypothesizes.
The report goes on to list five areas, organized into general statements, where the Senate hopes to focus its efforts:
- It costs too much to bring medical products through the pipeline to patients.
- As science and technology advance, the discovery and development process takes too long for medical products to make their way to patients.
- FDA’s responsibilities have grown to include many activities unrelated to the core function of regulating medical products to advance the public health.
- The disparity in scientific knowledge at FDA and the fast pace of biomedical innovation are slowing, and in some cases, stifling, innovation in American medicine.
- A working FDA is essential to continuing biomedical innovation in the United States and maintaining America’s global leadership in medical innovation.
Legislators are also eyeing expedited pathways for medical products—an idea that was fleshed out in the E&C's draft of the 21st Century Cures Act.
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