• Updated: FDA to Testify Before Senate Hearing on PDUFA, MDUFA

    [Editor's note: an earlier draft of this article incorrectly claimed the hearing was on 28 March. The hearing is being held on 29 March, 2012] A Senate hearing is scheduled to hear testimony Thursday(29 March) on the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) , marking the first hearing on either piece of legislation in the Senate. Directors Janet Woodcock of the US Food and Drug Administration's (FDA) Center for Drug Evaluat...
  • Shuren: Predicate Device 'Loophole' Must Be Closed

    The head of the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is calling for the end to a so-called "loophole" in the 510(k) medical device approval pathway . In remarks to Bloomberg News , CDRH Director Jeffery Shuren said that the agency needs new authority to reject new devices that are seeking approval based on being substantially equivalent to predicate devices that were subject to safety recalls. The 510(k) application...
  • Hoping to Relax Regulatory Burdens, Medical Device Manufacturers Gain Clout on the Hill

    Medical device manufacturers, including their industry representatives, are gaining significant influence on Capitol Hill, reports The Star Tribune . The article notes that the industry, led by industry association AdvaMed, has been working hard with legislators and lobbyists alike to advance initiatives that would reduce their regulatory burdens. Among the recent political developments that are favorable to the industry: A bill to change the US Food and Drug Admini...
  • MDUFA Hearing Tomorrow, FDA's Shuren to Testify

    The House Energy and Commerce Committee is scheduled to hold a hearing on 15 February on the Medical Device User Fee Act (MDUFA) reauthorization. Testimony will be heard from Jeffery Shuren , the director of the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), and several other prominent industry and patient representatives. FDA and industry representatives came to a deal "in principle" on the MDUFA legislation on 1 February ...
  • Whistleblowers Accuse FDA of Monitoring Correspondence to Congress About Medical Device Concerns

    A group of former staff scientists at the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) are accusing FDA of monitoring their interactions with Congressional staffers after FDA found that the staff scientists were submitting whistleblower complaints to Congress. Six staff scientists, former employees of CDRH's Office of Device Evaluation (ODE), first brought their concerns about the safety of some medical devices to FDA in 200...
  • Consumers Union Gears Up To Go After 510(k) Program, Urges MDUFA Markup

    Consumers Union, best known for their Consumer Reports publication, is launching a campaign to persuade Congress to force manufacturers using the 510(k) medical device regulation pathway to subject their products to the same premarket safety and efficacy tests that are required of pharmaceutical products. The 510(k) pathway is used by medical device manufacturers, and requires that manufacturers notify the US Food and Drug Administration (FDA) that they plan to market ...
  • Shuren Calls For Advances in Regulatory Science, Public-Private Medical Device Partnership

    Jeffery Shuren, the director of the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) commented this week that he believes that the center is becoming more predictable, transparent and efficient, reports Xconomy . Shuren has been traveling often over the last 24 months as part of a series of "town hall" meetings meant to engage with medical device manufacturers and the public and promote agency accessibility. Speaking at a meet...
  • Dates for PDUFA, MDUFA, GDUFA Committee Hearings Announced, Top FDA Officials to Testify

    The Energy and Commerce Committee of the US House of Representatives announced Thursday that its Health Subcommittee will hold hearings on the Prescription Drug User Fee Act (PDUFA) reauthorization,  Medical Device Use Fee (MDUFA) Act reauthorization, and the authorization of the Generic Drug User Fee Act (GDUFA). The subcommittee will hold its first hearing on PDUFA on 1 February and call US Food and Drug Administration (FDA) Commissioner Margaret Hamburg ...