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510k

US Regulators Plan Overhaul of Third-Party 510(k) Review Program

EMERGO SUMMARY OF KEY POINTS:

  • US FDA is amending its 510(k) third-party review program 3PRO to reduce the need for agency re-reviews of these submissions and market entry delays.
  • As part of the 3PRO overhaul, FDA will adjust its list of eligible devices to focus more on lower-risk, less complex products.
  • By 2021, FDA wants 85% of 3PRO-reviewed 510(k) submissions to go through without the need for agency re-review.

Venture Capitalists Lobbying Congress Heavily to Reign in FDA

Venture capitalists are spending significantly on efforts to lobby the US Congress to ease FDA regulatory requirements for medical device manufacturers, to considerable effect. According to a New York Times report, venture capital funds allocating to medical device and technology manufacturers have provided more than $3.3 million in political donations to lawmakers and political action committees over the past five years.

FDA Plans Reduced Medical Device User Fees for 2012

The US Food and Drug Administration will reduce medical device user fee rates for its 2012 fiscal year, due to $9.5 million in excess appropriations from 2011. The new rates have been published as US legislators and industry lobbying groups are aggressively questioning FDA arguments for fee increases when the Medical Device User Fee and Modernization Act comes up for renewal next year.