• As Medical Marijuana Hits Mainstream, Regulators Take Notice With Safety Recalls

    In the US, states are increasingly squaring off against federal regulators in an attempt to grant their citizens access to medical marijuana, which advocates argue can provide pain relief to patients afflicted with cancer or other painful conditions. But north of the US border, where medicinal marijuana is legal when authorized by a doctor or nurse practitioner, Canadian regulators are grappling with another marijuana issue entirely: The recall of medicinal marijuana due...
  • FDA Cracks Down on Transvaginal Mesh, Will Require Companies to Submit Data or Pull Products

    The US Food and Drug Administration (FDA) has announced that it will seek to regulate transvaginal mesh products more stringently, calling them high-risk devices that will be required to undergo FDA's thorough premarket approval (PMA) process. Background Transvaginal mesh has been used to treat female urological conditions, and in particular those caused by weakened pelvic muscles, which can lead to a pelvic organ prolapse (POP). In the EU, they have been used since the...
  • FDA Loosens Regulatory Controls on Stair-Climbing Wheelchairs

    The US Food and Drug Administration (FDA) has decided to down-classify stair-climbing wheelchairs from class III to class II medical devices, meaning they will no longer require premarket approval. Background In the US, medical devices are classified according to risk. Class I medical devices represent the least risk to patients, and are often exempt from premarket regulatory oversight (so long as they meet FDA-defined standards). Class III devices represent the oppos...
  • China Announces Major Overhaul of Device Regulation

    On 31 March 2014, the China Food and Drug Administration (CFDA) and China's State Council Legislative Affairs Office announced the first major overhaul of the regulations governing medical devices since the system's inception in April 2000.  The end product of six years of effort, the amended Regulations on the Supervision and Administration of Medical Devices are scheduled to go into effect on 1 June 2014, with additional implementing rules to be released over...
  • UDI Implementation Still on the Horizon, FDA Updates List of Devices Which Must Be Tracked

    A new guidance document released by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) updates the agency's list of devices that manufacturers are required to track by law. Background In 1997, the Food and Drug Administration and Modernization Act (FDAMA) was signed into law. Among the law's numerous requirements is one that manufacturers track specified devices at the order of FDA. The statute, codified in the Federal Food...
  • FDA Moves Ahead With Plan to Make Device Recall and Removal Reporting More Efficient

    In June 2013, the US Food and Drug Administration (FDA) indicated that it was interested in making it easier to submit so-called "806 reports"-filings made to report the removal or correction of a medical device from the market for reasons related to human safety. Now the agency is moving forward with that proposal, submitting it this week for final government review. Background Under  21 CFR 806.10 , companies are required to make written "reports of corrections...
  • Brazil Launches New Adverse Event Reporting System

    Brazilian officials are launching an online system for health professionals to report serious or fatal accidents involving defective products or services, including healthcare products.  Health professionals will log adverse events involving drugs, devices, toys, cosmetics and food into a new Consumer Accidents Information System (SIAC) database, initially on a voluntary basis. Reporting will eventually be mandatory. Top of Form The Municipal Hospital of Cuiab&aacu...
  • FDA Unveils Strengthened Medical Device Reporting Database With New Features

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has unveiled new improvements to its medical device recalls database, allowing members of industry and the public to more easily associate devices and safety recall issues. Prior to the new database, searches for a device yielded separate results for its labeling/approval information and any recalls. This could be problematic for healthcare providers, who would have no way of kn...
  • FDA Reclassifies Ophthalmic Device, Issues Special Controls

    The US Food and Drug Administration (FDA) has announced that it will reclassify stainless steel scleral plugs as class II medical devices, thereby allowing the devices to be approved under the premarketing notification process [510(k)] instead of the premarket approval process. Background Scleral plugs are used to temporarily close scleral-the sclera is the white of the eye-incisions made during eye surgery. For example, during a trabeculectomy, a small circular hole is...
  • USPlabs Succumbs to Regulatory Pressure, Recalls Supplement Linked to Hepatitis Outbreak

    Dietary supplement manufacturer USPlabs has announced the recall of one of its workout supplements, succumbing to vigorous pressure from regulators who said the company's products had been associated an outbreak of non-viral hepatitis. Background In early October 2013, US Food and Drug Administration (FDA) issued a statement saying that it was coordinating with the Centers for Disease Control and Prevention (CDC) to investigate 29 cases of acute non-viral hepatitis as...
  • Device Recalls Surge While Pharma Offers Mixed News in Latest Recall Report

    A report published this week by the recall consulting group ExpertRecall analyzing the number of recalls in the regulated healthcare product sector shows that both pharmaceutical and medical device recalls continued to fall within historical norms, even as both fluctuated-for better and for worse-from previous quarters. Background In the US, the recall of pharmaceutical and medical device products is largely conducted on a voluntary basis by companies, who often wish to...
  • Organic Particulates Lead to Recall for B.Braun Antibiotic

    The US Food and Drug Administration (FDA) has announced that B. Braun Medical (B.Braun) is voluntarily initiating a recall of one lot of its injectable antibiotic Cefepime after "visible organic particulate matter" was observed in a reserve sample unit. The drug, a combination of 1g Cefepime for Injection USP and Dextrose Injection USP, was first approved in May 2010 and comes in both 1g and 2g (approved in 2012) formulations.  It is indicated to "reduce the dev...