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  • Regulatory NewsRegulatory News

    Georgia Seeks to Shutter BD Device Sterilization Facility

    Georgia Attorney General Chris Carr earlier this week filed a complaint in court to temporarily halt Becton, Dickinson and Company (BD) from operating its Covington, Georgia medical device sterilization facility. Carr alleges that in September, BD released 54.5 pounds of ethylene oxide, which is often used to sterilize devices, into the atmosphere because of “a lack of diligence and prolonged operator error rather than an equipment malfunction.” He also said that the...
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    Device Industry Backs Proposed Changes to Anti-Kickback Statute, Stark Law

    Device industry group AdvaMed on Wednesday pledged its support for proposed the Department of Health and Human Services (HHS) changes to modernize and clarify the regulations that interpret the physician self-referral law, known as the “Stark Law,” and the federal anti-kickback statute. In addition to addressing concerns that these laws unnecessarily limit the ways in which health care providers can coordinate care for patients, the proposed rule from HHS’ Office of th...
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    AdvaMed and AAMI Weigh FDA Draft Guidance on Voluntary Consensus Standards

    Medical device industry group AdvaMed and the Association for the Advancement of Medical Instrumentation (AAMI) are seeking additional information from the US Food and Drug Administration (FDA) on draft guidance related to the recognition and withdrawal of voluntary consensus standards. The 8-page draft from September describes the procedures that FDA follows and the actions the agency may take during its review and evaluation of requests for standards recognition or ...
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    Congress Looks to Delay Medical Device Tax by 5 Years

    The House GOP are looking to bring together an 11th-hour fix to stop a tax on medical device companies from taking force as of 1 January 2018. The 2.3% tax, which was put in place by the Affordable Care Act but then delayed through the end of 2017, would be delayed another five years under the GOP bill . Industry group AdvaMed commended the leadership of House Ways & Means Committee Chairman Kevin Brady (R-TX) and Reps. Erik Paulsen (R-MN) and Jackie Walorski (R...
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    MedTech Industry Sees Challenges in Restarting Operations, Helping Puerto Rico

    With more than three million Americans in Puerto Rico facing no electricity because of Hurricane Maria, medical device and biopharmaceutical companies, many of which have manufacturing facilities on the island, are doing what they can to work with the US government to help their employees and restart operations. A spokesman from MedTech industry group AdvaMed told Focus at the group’s MedTech conference in San Jose, California on Monday that the group is working w...
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    AdvaMed Urges Supreme Court to Take Up Case on 510(k) Review Process

    Does a medical device cleared under the US Food and Drug Administration's 510(k) application mean that it is safe or that the device is just "substantially equivalent" to a legally marketed device? That's the question industry group AdvaMed wants the US Supreme Court to answer. In an amicus curiae brief filed with the nation's top court last week, AdvaMed takes issue with a decision from the US Court of Appeals for the Fourth Circuit, which upheld a $3.27 million j...
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    House Committee Considers Four Device Bills to Add to User Fee Reauthorization

    The House Energy & Commerce Committee on Tuesday discussed four bipartisan bills likely to be added to the user fee reauthorization package that aim to improve the US Food and Drug Administration’s (FDA) regulation of medical devices and inspections of device manufacturing sites. The committee discussed the bills with various experts and Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, who offered no opposition to any of the measure...
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    BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products

    Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations. Background Under what’s known as the pre-request for designation (pre-RFD) program, sponsors can ask FDA how their product will be classified (drug, device, biological product or combination product), and which of the agency's three review centers will be responsible for reviewing and reg...
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    AdvaMed CEO Confident of Device Tax Repeal This Year

    The Advanced Medical Technology Association's (AdvaMed) President and CEO Scott Whitaker said Tuesday he's confident that the medical device tax introduced under the Affordable Care Act will be repealed this year. Whitaker made the remarks during a call with reporters on Tuesday, where he also discussed potential changes to the US Food and Drug Administration's (FDA) inspection program for devices. Device Tax Repeal Despite the stalling of the Obamacare replacement b...
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    Failure to Reauthorize User Fee Programs Would Result in About 3,000 FDA Layoffs

    Representatives from the biotechnology, medical device and generic drug industries told members of the Senate Committee on Health, Education, Labor & Pensions on Tuesday that if the five-year user fee programs are not reauthorized, the US Food and Drug Administration (FDA) would likely see more than 3,000 job cuts. Those layoffs, if Congress and President Donald Trump fail to act before 1 August or Congress’ summer recess, would significantly curtail new medical product...
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    AdvaMed Boils Down Top Priority FDA Guidance Documents for 2017

    Medical device industry group AdvaMed pointed to seven guidance documents slated for release in 2017 by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health as those that are of the highest priority to its member companies. In addition to recommending that FDA finalize all of the draft guidances issued within the last year, the list of seven final guidance documents (of the 12 listed in FDA’s "A" list for 2017, meaning the agency has a...
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    Industry Group Links More Than 28,000 Job Losses to Device Tax

    As part of its push to fully repeal the medical device tax from the Affordable Care Act , industry group AdvaMed took to the offensive on Wednesday, saying US medical technology jobs declined by more than 28,000 (7.2%) while the 2.3% tax was in effect. Citing data from the Commerce Department, AdvaMed notes that from 2012 to 2015, the number of medical technology jobs in the US declined from 401,472 to 372,638, and though the group does not explicitly say the job loss...