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  • Feature ArticlesFeature Articles

    Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency for medical device manufacturers

    This article summarizes FDA enforcement policy during the early months of the COVID-19 public health emergency and outlines the regulatory considerations for temporary enforcement discretions. The authors emphasize the importance of routine and scientific communication between the FDA, industry, and providers to facilitate the long-term directions of these technologies.   Introduction Historically, the US Food and Drug Administration (FDA) has played an important rol...
  • Regulatory NewsRegulatory News

    FDA to Step Up Stem Cell Enforcement, Look Into Pathway for Low-Risk Treatments

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation Research (CBER) Director Peter Marks on Wednesday warned that the agency will step up its enforcement efforts against companies illegally marketing stem cell therapies.   Gottlieb and Marks also said the agency will look into new ways to “delineate an efficient development path” for low-risk stem cell therapies being developed by firms that have filed investigational n...
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    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...
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    FDA Warns Integra’s TEI Biosciences Over Contamination Issues

    A TEI Biosciences medical device facility drew an US Food and Drug Administration (FDA) warning letter earlier this month over failures to prevent bacterial contamination of certain manufacturing equipment and products. The warning letter, made public on Tuesday, cites four good manufacturing practice (GMP) violations for the manufacturer of collagen-based medical devices. The first three GMP violations cover a lack of procedures to control environmental conditions as w...
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    FDA Warns Pennsylvania Drugmaker Over GMP Violations

    The US Food and Drug Administration (FDA) last month warned Vilvet Pharmaceuticals over good manufacturing practice (GMP) issues and for failing to list two of its products with the agency.   The warning letter comes after a 10-day inspection of Vilvet’s Chester Springs, PA facility in June 2018.   According to FDA, Vilvet failed to establish and follow adequate quality control practices, including failing to review batches of drugs made by a contract manufacturer....
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    FDA Warns Spanish Firm Over GMP, Data Integrity Issues

    The US Food and Drug Administration (FDA) this month warned Spanish over-the-counter (OTC) drugmaker Proandre SL over good manufacturing practice (GMP) and data integrity issues that landed the firm on import alert in November.   FDA inspected Proandre’s Barcelona facility over the course of four days last June, finding that its OTC Proandre antibacterial soap and hand sanitizer liquid are adulterated and misbranded. Two other products are cited in the warning letter a...
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    FDA Cites GMP, GLP Violations at Two Sites

    The US Food and Drug Administration (FDA) posted two warning letters on Monday that flagged a total of nine violations of good manufacturing practice (GMP) at California-based Total Thermal Imaging (TTI) and four violations of good laboratory practice (GLP) at an American Preclinical Services (APS) facility in Minneapolis. TTI’s warning letter comes after an FDA inspection of its website and brochures concluded that its Thermographic Business Package lacked the approv...
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    Datascope Draws Second FDA Warning

    Getinge Group subsidiary Datascope failed to adequately conduct device design validation, establish procedures for corrective and preventive actions (CAPAs) and evaluate and select potential suppliers, according to a US Food and Drug Administration (FDA) warning letter. The warning letter was issued to the firm— acquired  by Getinge in 2008—on 6 February and made public Wednesday. It marks the second warning letter to the Getinge subsidiary. The first one was issued  l...
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    FDA Warns Two Drugmakers for GMP Violations

    The US Food and Drug Administration (FDA) recently warned two drugmakers, Phoenix-based Vasco Rx and Commerce, CA-based Samson Pharmaceuticals, for good manufacturing practice violations at their facilities.   Vasco Rx   FDA’s warning letter to Vasco Rx comes after the agency inspected the company’s manufacturing site in March and April 2018.   At the end of the inspection in April, Vasco Rx stopped production and later voluntarily recalled all sterile drugs pr...
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    FDA Warns Ocular Therapeutix Over Failure to Comply With Postapproval Requirements

    Ocular Therapeutix drew a US Food and Drug Administration (FDA) warning letter for failing to comply with post-approval study requirements (PAS) set as part of its ReSure Sealant’s conditional approval. The warning letter, dated October 2018, cites the company’s failure to collect any data for its FDA-approved protocol—identified as a Device Exposure Registry (DER) study—as part of the PAS requirements in the 4.5 years since the conditional approval. Ocular Therapeutix’...
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    FDA Warns Doctor Over Unapproved Device

    In a 14-violation US Food and Drug Administration (FDA) warning letter, the agency flagged a doctor’s website for significant deviations from FDA quality system requirements and good manufacturing practices (GMP), as well as illegally marketing an unapproved device for a complication of breast implants. The warning letter was issued to Mark Berman of Beverly Hills, California for marketing the implantable Pocket Protector device online with claims and use indications ...
  • 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...