<code id='A2D8027E88'></code><style id='A2D8027E88'></style>
    • <acronym id='A2D8027E88'></acronym>
      <center id='A2D8027E88'><center id='A2D8027E88'><tfoot id='A2D8027E88'></tfoot></center><abbr id='A2D8027E88'><dir id='A2D8027E88'><tfoot id='A2D8027E88'></tfoot><noframes id='A2D8027E88'>

    • <optgroup id='A2D8027E88'><strike id='A2D8027E88'><sup id='A2D8027E88'></sup></strike><code id='A2D8027E88'></code></optgroup>
        1. <b id='A2D8027E88'><label id='A2D8027E88'><select id='A2D8027E88'><dt id='A2D8027E88'><span id='A2D8027E88'></span></dt></select></label></b><u id='A2D8027E88'></u>
          <i id='A2D8027E88'><strike id='A2D8027E88'><tt id='A2D8027E88'><pre id='A2D8027E88'></pre></tt></strike></i>

          hotspot

          hotspot

          author:hotspot    Page View:61
          Photography of the US department of health and human services in Silver Spring MD
          Manuel Balce Ceneta/AP

          An increasing number of medical device companies are submitting fabricated and unreliable data, the Food and Drug Administration noted Tuesday morning. The data comes from third-party labs hired by device firms to test the quality of their products.

          Triple-check your data or we’ll reject your device, the FDA warned.

          advertisement

          The goal of third-party testing is to ensure a device meets the FDA’s standards in a range of areas, including biocompatibility, sterility, and mechanical performance. The agency wrote that it has noticed an uptick in false data submissions in recent years, particularly from facilities based in China and India. In some cases, the facilities will send data copied from previous device submissions.

          Get unlimited access to award-winning journalism and exclusive events.

          Subscribe Log In

          explore

          BioMarin wins approval for gene therapy to treat hemophilia A
          BioMarin wins approval for gene therapy to treat hemophilia A

          AdobeTheFoodandDrugAdministrationonThursdayapprovedagenetherapytotreatpeoplewithhemophiliaA,aninheri

          read more
          Adam's Take: Intra
          Adam's Take: Intra

          MollyFerguson/STATIamoneweekawayfromthelaunchofmyweeklyemailnewsletter!It’scalledAdam’sBiotechScorec

          read more
          Bright Health sells Medicare Advantage business to Molina
          Bright Health sells Medicare Advantage business to Molina

          BrightHealthisofficiallyleavingthehealthinsurancemarket.ThecompanyhasagreedtosellitsMedicareAdvantag

          read more

          Blood tests recalled over risk of missed heart attack diagnosis

          AdobeQuidelOrthohasrecallednearly8,000potentiallyfaultybloodtestsmeanttohelpdoctorsquicklydeterminew