FDA Initiates Program Requirement, Congress Targets Med-Tech

News sources reported that the US Food and Drug Administration’s (FDA) reviewer certification program will become an agency-wide requirement this month in the effort to have a more prepared staff and shorten medical device review times.

The training program is 18 months and will be required of all new device reviewers from the Center for Devices & Radiological Health’s (CDRH) anaesthesia, general hospital, infection control and dental devices divisions.

According to Dr. Jeffrey Shuren, CDRH chief, “We are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during the premarket device reviews. This investment will improve the quality of submission review and make the process more consistent and predictable.”

At the same time, the House Energy & Commerce Committee’s Health panel is set to focus on tweaking the FDA regulatory process for medical devices and prescription drugs in the effort of gaining a competitive edge on foreign markets with more favorable regulatory conditions. In a news release, the committee said, “The US traditionally has been the leader in the medical device industry employing an estimated 420,000 Americans, but the lack of predictability and consistency at FDA currently force research and development, manufacturing and new product approvals to Europe, costing American jobs and limiting US patients’ access to revolutionary new devices.”

The med-tech industry has frequently asked for more consistency and predictability from the agency. The new program requirement is aimed at provided such consistency.

As a Columbia personal injury lawyer , I’ve seen many recalls from the med-tech industry and know that they and the FDA work hard to prevent such events. While we don’t handle these types of cases, if you’ve been injured through the use of a defective medical product, it may be in your best interests to speak with a personal injury lawyer in your area.