FDA Review May Slow Clearance of Thousands of Medical Devices

approval process allowing medical products to reach the market is likely to get slowed down. The [U.S.] Food and Drug Administration (FDA; Silver Spring, MD, USA) 510(k)-review process, which often allowed products to be marketed without lengthy clinical trials, is under major review. An FDA memorandum suggests that the 510(k) program is already being tightened even before the policy review is complete.

The FDA action came after it became aware of outside influences, in the form of political pressure, to the integrity of its approval process. The federal agency also commissioned an external group to look into the.

The 510(k) approval process streamlines clearance for products deemed substantially equivalent to those already on the market — a policy, which when positively viewed tended to build on existing knowledge, but one that at times had the potential to go astray. As more guarded FDA reviews are expected, device makers claim that a lengthier approval process would raise development costs and erect barriers to market entry, reducing competition.

Advanced Medical Technology Association, a medical industry body, has raised concerns with regard to the new policy. David Nexon, the association's senior executive vice president said that the industry supports the review so long as reasonable standards are applied with consistency and transparency.

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