• Warning Letter Analysis: Device Companies, Tissue Bank Hit Hard for Deficiencies

    • 30 May 2012
    The US Food and Drug Administration's (FDA) newest batch of warning letters was released on 29 May 2012, and some familiar faces have come under further scrutiny. Medical device manufacturer McNeil PPC, a subsidiary of Johnson & Johnson, was hit with a lengthy list of claims by FDA, which said the firm is manufacturing no fewer than ten adulterated products. Three of the company's Pennsylvania facilities are currently the subject of an FDA consent decree after the...
  • FDA Cites Military-tech Company for Marketing Medical Device Without Approval

    A company marketing several medical devices intended to be used in combat situations has been cited by the US Food and Drug Administration (FDA) for marketing one without having sought approval from the agency and manufacturing numerous others in violation of current good manufacturing practices. In a warning letter released 9 May, FDA said Virginia-based manufacturer H&H Associates does not have "an approved application for premarket approval in effect" pursuant to ...
  • Senator: Regulators and Medical Device Manufacturers Must Find Common Ground

    Minnesota Senator Al Franken (D-MN) told media present at the Design of Medical Devices Conference he doesn't believe there needs be a choice between having medical devices be proven safe or having those devices be brought to market quickly, reports The Star Tribune . "To some degree, there is a false choice there," said Franken, a member of the Senate Health, Education, Labor and Pensions Committee which oversees the US Food and Drug Administration. The way forward, e...
  • CDRH Releases New Training Module for Guidance on Benefit-Risk Determinations

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released a new training module on a guidance document released by the agency that focuses on making benefit-risk determinations for medical device submissions. FDA's guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications , was released 27 March 2012. FDA noted at the time of the guidance release ...
  • GAO: Medical Device Reviews Taking Longer Despite FDA Meeting Goals

    The US Government Accountability Office (GAO) released a report Thursday (29 March) indicating it found the US Food and Drug Administration (FDA) to be meeting its performance goals for medical device reviews, but that overall medical device review time was trending upward. The discrepancy comes down to a difference in how FDA's performance is evaluated relative to the total time it takes to review a medical device under the 510(k) evaluation pathway. Under so-called "...
  • FDA Releases New Guidance For Industry for Benefit-Risk Evaluations in PMAs, De Novo Classifications

    The US Food and Drug Administration (FDA) released new guidance on 27 March for benefit-risk determinations in premarket approvals (PMAs) and de novo classifications for medical devices. The guidance, Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications , "is intended to provide greater clarity on FDA's decision making process," FDA wrote. According to the guidance document, "this guidance sets o...
  • FDA Releases PMA Summaries for Q4 2011

    The US Food and Drug Administration (FDA) is updating its list of available safety and effectiveness summaries of Premarket Approvals (PMAs) to include all decisions made in the fourth quarter of 2011. The updated list includes the PMA docket number, applicant, trade name of the product and the product's approval date, as well as the complete safety and effectiveness summary by FDA. All 15 products added to the list during the 4 th quarter of 2011 were approved. Under...