• Regulatory NewsRegulatory News

    Device Recalls in 2017: Making Sense of the Numbers

    Each year, the US Food and Drug Administration (FDA) designates anywhere from dozen to hundreds of medical device recalls as Class I, indicating that the risk addressed by the recall could potentially cause serious injury or death. But it can be difficult to quantify the number of device recalls in a year, given the multiple data sources from FDA, including a listing of annual Class I and other significant recalls , a device recalls database and a data dashboard . B...
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    FDA Announces Streamlined Review Pathway for DTC Genetic Tests

    The US Food and Drug Administration (FDA) on Monday detailed its plans to make it easier for companies developing direct-to-consumer (DTC) genetic health risk (GHR) tests to get those tests on the market. To do so, FDA is proposing a model similar to a pilot for digital health products, by which companies can be pre-certified to market low-risk software-based devices following an assessment of their systems for software design, validation and maintenance. Similarly, F...
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    FDA Warns of Bacterial Contamination in PharmaTech Liquid Drugs

    The US Food and Drug Administration (FDA) on Wednesday warned patients and health care professionals not to use liquid drugs made by Florida-based contract manufacturing organization (CMO) PharmaTech LLC due to possible bacterial contamination. Last week, Rugby Laboratories issued a voluntary nationwide recall of all lots of two liquid docusate sodium laxatives, Diocto Liquid and Diocto Syrup, made by PharmaTech due to possible Burkholderia cepacia contamination. Wh...
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    FDA Finalizes List of 1,003 Class II Device Types Exempt From 510(k) Requirements

    The US Food and Drug Administration (FDA) on Monday finalized a list of 1,003 types of class II medical devices that the agency believes do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. Established under the 21st Century Cures Act, the list, first published in draft form in March , is part of efforts to decrease regulatory burdens and costs for the device industry. For the complete f...
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    BD, Roche Weigh FDA’s Proposed Exemptions for Class II Devices

    Beckton, Dickinson and Co. (BD) and Roche Diagnostics are seeking clarifications and changes to the US Food and Drug Administration’s (FDA) proposed list of Class II medical devices to be exempted from premarket notification. The comments follow the release in March of FDA’s draft list , which was released as part of a provision in the 21st Century Cures Act . The devices listed include lots of basic diagnostic tests and reagents, as well as other equipment like ...
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    FDA Identifies More Than 70 Class I Devices Now Exempt From 510(k) Requirements

    As part of its implementation of the 21st Century Cures Act, the US Food and Drug Administration (FDA) on Wednesday released a list of more than 70 Class I medical devices that are now exempt from premarket notification requirements. “FDA’s action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation,” the agency said in a notice. The list includes a range of ...
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    FDA Drafts List of Class II Devices to be Exempt From Premarket Notification

    The US Food and Drug Administration (FDA) began implementing the recently passed 21st Century Cures Act on Monday by publishing a draft list of class II devices that will be exempt from premarket notification requirements, or 510(k)s. FDA said in a statement that it “believes that the devices identified in the Federal Register are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safe...
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    House Bill Seeks to Add Mandatory Drug Recall Authority to FDA’s Arsenal

    Rep. Rosa DeLauro (D-CT) on Thursday introduced a new bill that will allow the US Food and Drug Administration (FDA) to do what many assume it already can: Require pharmaceutical or over-the-counter drug companies to stop marketing unsafe products. The Recall Unsafe Drugs Act would give FDA mandatory recall authority over drugs and homeopathic products. The agency confirmed to Focus that it does not have that authority. The loophole is problematic in that some compani...
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    CDRH Speeds Release of Device Recall Information

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday began posting medical device recall information in a searchable database much earlier than the agency ever has before. The information is now posted in CDRH’s Medical Device Recalls Database at the time a firm takes a correction (which addresses a problem with a device in the place where it is used or sold) or removal action (ie., Removing the device from the market...
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    FDA Classifies Post-Concussion Test

    Months after clearing the first computer-based test intended to measure cognitive function after a suspected concussion, the US Food and Drug Administration (FDA) on Monday said it considers such devices to be Class II, or moderate risk devices. In August, FDA cleared ImPACT Applications' Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric devices via its de novo classification pathway, as no similar devices had been previously cl...
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    EMA Sets Deadlines for 2016 Type I Variations

    The European Medicines Agency (EMA) on Monday said that marketing authorization holders (MAHs) need to submit any minor changes to drug marketing authorizations, also known as Type IA IN and Type IA variations, for 2016 by 30 November. MAHs are also advised to submit any Type IB variations or groupings of Type IB and Type IA variations in 2016 by 13 December 2016. The deadlines have been set so that EMA can acknowledge the validity of the submissions before the age...
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    FDA Extends UDI Compliance for Certain Class II Devices

    The US Food and Drug Administration (FDA) is giving medical device labelers two more years to comply with unique device identifier (UDI) requirements for certain Class II devices. In a letter to device labelers dated Tuesday, FDA said it is extending the UDI compliance dates for so-called device convenience kits and repackaged single-use devices and is clarifying the compliance date for device constituents for certain combination products. Under the UDI rule, FDA establ...