• Regulatory NewsRegulatory News

    FDA, DHS Alert to Cybersecurity Flaws Affecting Medtronic Cardiac Devices, Programmers, Monitors

    Hundreds of thousands of units of Medtronic implantable cardiac devices, programmers and home monitors are vulnerable to cybersecurity incidents, according to two US federal government notices. On Thursday, the US Food and Drug Administration (FDA) issued an FDA safety communication, while the US Department of Homeland Security's (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory to flag cybersecurity vulnerabilities detected in...
  • Regulatory NewsRegulatory News

    Breast Implant Manufacturers Draw FDA Warning Letters Over Post-Approval Studies

    The US Food and Drug Administration (FDA) sent warning letters this week to two breast implant manufacturers over their failures to comply with FDA’s post-approval study (PAS) requirements. The warning letters were made public by FDA late Tuesday and sent to Sientra and Mentor Worldwide on Monday for being in violation of two of the seven requirements established as part of their devices’ conditional approvals. They underscore an emerging FDA enforcement trend around PA...
  • Regulatory NewsRegulatory News

    FDA Urges Caution in Use of Robotic Surgical Devices for Cancer-Related Procedures

    Patients and health care providers should know that the safety and effectiveness of robotically-assisted surgical devices for the prevention or treatment of cancer has not been established for use in the US, a US Food and Drug Administration (FDA) safety communication warned on Thursday. The safety communication urges caution when using robotically-assisted surgical devices for mastectomy and any other cancer-related surgery, citing the lack of FDA evaluation on use of ...
  • Regulatory NewsRegulatory News

    FDA Alerts on Increased Risks Linked to Pfizer’s Xeljanz

    The US Food and Drug Administration (FDA) alerted the public late Monday of a post-marketing safety clinical trial for Xeljanz (tofacitinib) that found an increased risk of lung blood clots and death in patients with rheumatoid arthritis (RA) who were taking a dose of 10 mg twice daily. The drug safety communication noted the increased risk was observed in the post-marketing trial set as a requirement on Pfizer following the first approval  of Xeljanz in 2012. It comes...
  • Regulatory NewsRegulatory News

    Swissmedic Updates on Breast Implant Associated-anaplastic Large Cell Lymphoma

    Swissmedic said Monday that based on the currently available information, the association Swiss Plastic Surgery recommends using smooth implants rather than textured implants where permitted by the clinical situation. France’s National Agency of Medicine and Health Products (ANSM) echoed that recommendation after observing most known breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) cases in patients with textured breast implants. But the committee doe...
  • Regulatory NewsRegulatory News

    E&C Leaders Seek FDA Briefing on Contaminated Sartans

    A bipartisan group of lawmakers who serve on the US House Committee on Energy and Commerce (E&C) sent a letter to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday to request a briefing on the sartan safety issues that prompted a string of recalls worldwide. “Beginning in July 2018, there have been at least 15 recalls issued for a variety of angiotensin II receptor blockers (ARB), which are generally used to treat high blood pressure,” the E...
  • Regulatory NewsRegulatory News

    Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal Mesh

    A panel of outside experts convened by the US Food and Drug Administration (FDA) on Tuesday deliberated on available evidence and patient testimonies regarding the use of transvaginal mesh implants and advised the agency to consider adverse event reports when conducting premarket reviews. The panel, which was largely compromised of medical doctors, heard from patients who experienced a range of health complications following implantation of the surgical mesh. This marke...
  • Regulatory NewsRegulatory News

    Combo Product Reviews: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Tuesday released high-level draft guidance explaining the principles for premarket review of combination products, including how sponsors can determine which type of premarket submission is appropriate. The 22-page draft, which implements a section of the 21 st Century Cures Act , explains what combination products are, how their various FDA center assignments are determined and considerations for making approval pathway de...
  • Regulatory NewsRegulatory News

    FDA Flags Higher Death Rates Linked to Use of Abiomed Heart Pump in Post-approval Study

    A temporary heart pump manufactured by Massachusetts-based Abiomed prompted a US Food and Drug Administration letter to health care providers on Monday over an increased rate of mortality. The letter cites interim results from Abiomed’s January report on a post approval study (PAS) that was mandated by the agency as a condition for the 2017 FDA approval of the Abiomed Impella RP System. “A total of 44 out of 60 patients (73.3%) survived to 30 days post device explant...
  • Regulatory NewsRegulatory News

    510(k) Modernization: FDA Floats Need to Pursue New Authority

    Plans at the US Food and Drug Administration (FDA) to “modernize” the most commonly used pathway for new medical device clearances “might require new authority,” FDA leadership said on Monday. FDA Commissioner Scott Gottlieb and Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), issued a joint statement to announce 2018 progress on novel device approvals, pointing out that the breakthrough 510(k) is one of two submission types that was new...
  • Regulatory NewsRegulatory News

    European Commission Updates Q&A on Safety Features for Medicinal Products

    The European Commission recently released an updated document setting out nine new and one revised frequently asked questions and answers on the implementation of the rules on the safety features for medicinal products for human use. Building off a previous update in November , five of the new questions deal with general issues, like whether medicinal products can carry more than one batch number, or whether during the transitional period manufacturers located in the E...
  • Regulatory NewsRegulatory News

    CDRH Outlines Next Steps to Implement New Safety and Performance Based Pathway

    Following Tuesday’s final guidance that established a new option for 510(k) clearance, a spokesperson from the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) highlighted next steps to implement the new Safety and Performance Based Pathway in 2019. “Our next step is to develop an implementation plan to apply this Safety and Performance Based Pathway,” CDRH spokesperson Angela Stark told Focus . “We encourage industry and o...