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  • Regulatory NewsRegulatory News

    GS1 Guideline Seeks to Help Implement FDA’s UDI Requirements

    GS1 US recently updated its unique device identification (UDI) implementation guideline, with new instructions on device identifiers (DIs), production identifiers (PIs), human readable information (HRI) and direct marking. The implementation guideline was updated to reflect the policy changes and clarifications that FDA has issued since the guideline’s 2014 version. The updates added information on the two UDI segments, including new details on the GS1 Global Trade Item...
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    EC Releases New Batch of MDR Eudamed Guidelines

    In the latest batch of documents on Eudamed under the EU’s medical device regulation (MDR), the European Commission (EC) issued guidelines on data exchange solutions and data exchange services. A 7-page document sets forth new guidelines to aid decision-making among competent authorities, notified bodies and economical operators, including device manufacturers and authorized representatives, on data exchange solutions for compliance with MDR’s future version of Eudame...
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    NESTcc Advances Data Quality and Study Design Frameworks

    The National Evaluation System for health Technology Coordinating Center (NESTcc) on Tuesday unveiled two frameworks on data quality principles and study design methods for medical devices. The data quality framework is intended to serve as a guide to support high quality device data among NESTcc network collaborators and other organizations, whereas the methods framework serves as a “living playbook” for NESTcc to promote pre-specifications in prospective studies. T...
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    IMDRF Seeks Input on Regulatory Pathways for Personalized Medical Devices

    In a new proposal to harmonize regulatory pathways for personalized medical devices, the International Medical Device Regulators Forum (IMDRF) is looking to crack down on the “questionable use of custom-made device exemptions” that some countries have been noticing. The IMDRF personalized medical devices working group (WG) makes note of technology’s evolution, which has allowed products to be targeted to an individual, as well as the ways in which custom-made devices ha...
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    CDRH Outlines Vision for Good Machine Learning Practices

    Ahead of the deadline for feedback on the US Food and Drug Administration’s (FDA) discussion paper on artificial intelligence (AI) and machine learning (ML), FDA’s medical officer for digital health Matthew Diamond detailed the vision for good ML practices (GMLP) at the AdvaMed Digital MedTech Conference. GMLP “would be analogous to good manufacturing practices (GMP)” in applying a quality system approach, though it would be “specifically focused on the unique challenge...
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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...