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    Experts Discuss CDRH Proposals That May Require New Authorities

    From a pre-certification (PreCert) approach on software as a medical device (SaMD) and laboratory-developed tests (LDTs) to cybersecurity and the 510(k) premarket review pathway, the US Food and Drug Administration (FDA) has set forth several proposals that may require additional statutory authority. Legal experts at the AdvaMed Digital MedTech Conference in San Francisco this week shed light on the specific areas within FDA’s existing statutory authority that pose ques...
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    Experts Examine Impact of EU GDPR, CCPA on MedTech Sector

    An expert panel at the AdvaMed Digital MedTech Conference in San Francisco on Wednesday discussed the impact on the medical technology sector from new legislation that enacted changes to privacy rights and data protection. Last year saw some major changes to regulation in US and EU law on data privacy and protection. To enhance privacy rights and data protection, the EU’s General Data Protection Regulation (GDPR) was implemented last May and the California Consumer Priv...
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    FDA Warns Orthopedic Implant Manufacturer Over Quality System Violations

    The US Food and Drug Administration (FDA) issued a warning letter to Orchid Orthopedic Solutions over violations linked to the agency’s quality system regulation, including inadequate complaint handling procedures. The warning letter cites a total of six violations. These became significant violations after the manufacturer of orthopedic implants failed to ease the agency’s concerns initially noted in a Form 483, following a 12-day inspection in February at the company’...
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    FDA Updates Mortality Rate Linked to Heart Pump in Post-Approval Study

    Patients in a post-approval study (PAS) for Abiomed’s heart pump Impella RP reported lower survival rates when compared to premarket studies, the US Food and Drug Administration (FDA) reported Tuesday. The update from the latest PAS report indicates 28.6% (12 out of 42 patients) met the primary survival endpoint, which compares with 17.4% (4 out of 23 patients) reported in February. Despite the higher rate of mortality, FDA said that when the device is used “for th...
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    FDA 483s Pile Up in Crackdown on Sartan Manufacturers in India

    In line with efforts to assess the impact and sources of the sartan safety scandal, India-based Torrent Pharmaceuticals and Cadila Healthcare separately drew lengthy US Food and Drug Administration (FDA) Form 483s over, among other issues, failures to thoroughly review unexplained discrepancies. The manufacturing site inspection at Torrent Pharmaceuticals FDA investigators conducted over the course of about a week last month resulted in four inspectional citations, with...
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    Patient Use of Unapproved Diabetes Management Devices Poses Insulin Dosing Risks, FDA Warns

    The US Food and Drug Administration (FDA) issued a safety communication Friday to warn about adverse event risks in patients’ use of diabetes management devices lacking approvals or clearances. The safety communication raises the agency’s concerns about whether patients are fully aware of the risks of adverse events when using continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems or components that have not undergone FDA review. FDA e...
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    WHO Stresses Role of GMP in Combatting Antimicrobial Resistance

    The World Health Organization (WHO) issued a draft document Wednesday on environmental aspects of good manufacturing practices (GMP) to aid inspectors and manufacturers of antimicrobials. The 24-page document is intended to raise awareness on interpreting relevant GMP guidance sections applicable to managing waste and wastewater from antimicrobials’ production, considering all GMP implementation aspects and focusing on critically important antimicrobials to establish an...
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    Q&A: A New Society Targets Digital Medicine Alongside FDA Officials

    The Massachusetts-based Digital Medicine Society (DiMe) launched this week with a strategic advisory board that includes Amazon, as well as top drugmakers like Novartis, and a scientific leadership board including US Food and Drug Administration (FDA) officials. Among the FDA officials on its scientific leadership board are Bakul Patel, digital health director at FDA’s Center for Devices and Radiological Health (CDRH), CDRH’s lead of cybersecurity initiatives, Suzanne S...
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    BD’s CareFusion Agrees to $3.3M DOJ Settlement Over Unapproved Devices

    CareFusion, a subsidiary of Becton Dickinson (BD), agreed to a $3.3 million settlement to resolve allegations of civil fraud under the False Claims Act over purchases and sales of unapproved devices. The case was brought on by the US Department of Justice (DOJ) and alleged that providers who used CareFusion devices in medical procedures submitted false claims to federal insurance programs, such as Medicare. The devices allegedly lacked US Food and Drug Administration ...
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    FDA Unveils 34 New and Revised Product-Specific Draft Guidances

    The US Food and Drug Administration (FDA) on Wednesday released its latest batch of product-specific guidance documents to support the development of generic drugs, with 25 new and nine revised draft guidances. HIV antiretrovirals and antibiotics topped the list of new draft guidances with a total of five, followed by drug products containing active ingredients to treat ophthalmic ailments and cancers. Among the revised product-specific drafts is one for azelaic acid an...
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    Repeat GMP Violations Spur FDA to Ban Canadian OTC Drugmaker Imports

    A US Food and Drug Administration (FDA) inspection at a Canada-based over-the-counter (OTC) drug manufacturing facility revealed violations of good manufacturing practices (GMP)—similar to those cited in 2012 and 2014. A new FDA warning letter cites Petra Hygienic Systems International for four violations of GMP regulations for finished pharmaceuticals, following the site inspection FDA conducted last December. Imports from the firm have been blocked from entering the U...
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    FDA’s Proposal to Limit Device Predicates Fails to Garner Industry Support

    The medical device industry is criticizing a US Food and Drug Administration (FDA) proposal to limit the use of older predicate devices, citing misconceptions about the 510(k) pathway, hindered market access, stifled innovation and competition and more regulatory burdens. The comments on the November 2018 proposal argue that a limit on manufacturers’ use of predicates would be a setback from improvements made to the program since its 1976 enactment. The 510(k) path...