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Medical Devices

December 16, 2011 | Daily News

The medical device industry objected to the bill soon after it was introduced Thursday (Dec. 15), saying FDA already has enough authority to ensure device safety, but a key public interest group said the bill should go further and scrap the 510(k) process entirely.

The debate on the issue is likely to continue into next year, as the senators said they will push for inclusion of their bill -- which would also boost FDA's recall authority -- as part of the medical device user fee reauthorization on tap for 2012.

October 28, 2011 | Daily News

A new association with ties to the drug and device industries plans to lobby policymakers about the effects of government regulation on life science innovation, and will push to eliminate the health reform law's Independent Payment Advisory Board, nix Medicare Part D rebate proposals under consideration by the debt law's super committee and change the FDA regulatory process.

October 26, 2011 | Daily News

House Republicans are pushing legislation that would give FDA 15 months to downclassify or complete premarket reviews for older, high-risk medical devices, reaffirming an older directive by Congress that wasn't met, although the agency has already set a goal of completing this process by the end of 2012.

October 24, 2011 | Daily News

The Obama administration wants countries negotiating the Asia-Pacific regional trade agreement to harmonize their Unique Device Indicator (UDI) systems to track medical devices and align drug review application formats as part of negotiations on the pact, known as the Trans-Pacific Partnership (TPP) agreement, according to leaked negotiation documents released by the non-profit advocacy group Public Citizen.

October 21, 2011 | Daily News

Pediatric advocates are concerned a new GOP bill that would expand profit eligibility to include adult-only humanitarian use devices would negate the pediatric incentives that spurred an increase in the development of medical devices for children, they say in a letter to House lawmakers Thursday (Oct. 20). Rare disease advocates and the device industry, meanwhile, are supporting the legislation.

October 14, 2011 | Daily News

House Republicans -- primarily on the Energy and Commerce Committee -- introduced 10 bills Friday (Oct. 14) to revamp FDA, including legislation to change the agency's mission to add facilitation of innovation, amend FDA advisory committee conflict-of-interest rules, mandate FDA harmonize requirements with some international regulators, encourage utilization of third-party device reviews, thwart FDA review of laboratory-developed tests, and allow device manufacturers to use the de novo review process for novel devices without filing 510(k) clearance applications first.

October 07, 2011 | Daily News

FDA and some medical device companies are grappling with whether safety improvements to marketed products require a recall of devices already distributed or even a new 510(k) clearance application, with the agency developing guidance and other procedures on how to assess changes and action required of the manufacturer, industry and FDA sources said recently.