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Medical Devices

January 31, 2012 | Daily News

FDA is pushing ahead with its innovation pathway for novel medical devices with a pilot project for end-stage renal disease that one stakeholder said could provide inroads to comparative effectiveness research and despite calls from the medical device industry for the agency to focus on bringing greater efficiency and consistency to the overall review process.

January 28, 2012 | Daily News

Free speech advocates are using a district court case as an opportunity to challenge FDA guidance released last year outlining the difference between drugs and devices, with the advocates saying the agency's policy conflicts with the statutory definition of medical devices.

January 25, 2012 | Daily News

The medical device industry and FDA are in the final stages of an agreement on medical device user fees, closing in on a package that includes around $600 million in fees over five years and abandons recent proposals to hike fees in the middle of the program, several sources said. When finalized, the agreement would conclude months of contentious negotiations between the agency and industry over the amount of the fees to be paid by companies, with the talks prompting involvement from FDA's top official and debate on Capitol Hill.

January 21, 2012 | Daily News

Democratic leaders of the House Energy and Commerce Committee on Friday renewed their call for hearings to examine the safety of implantable medical devices ahead of reauthorization of medical device user fees, an area where safety advocates are pushing for a more rigorous premarket approval process. Such oversight could also have implications for CMS coverage and reimbursement policy.

January 17, 2012 | Daily News

Key Senate lawmakers on Friday (Jan. 13) called for FDA and the medical device industry to resolve issues surrounding user fee negotiations as drug agreements – including industry fees for the health reform-created biosimilars pathway – were submitted to Congress ahead of a Jan. 15 statutory deadline. Device talks, however, have been stalled over fee level disagreements, with the agency pushing industry to contribute higher levels of user fees for device reviews.

January 10, 2012 | Daily News

Medical device stakeholders said changes to the de novo approval process and conflict of interest rules are legislative reforms that will likely ride along with user fee legislation, while other device reforms could also be included in the agreement being negotiated by FDA and industry. The agency's use of its post-market authority for medical devices is also likely to be a major and possibly contentious issue as the user fee bill is debated on Capitol Hill, while safety advocates said they plan to push for the more rigorous premarket approval process for all implantable 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.

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