Archive for January 2019
Canada Issues Guidance on Cybersecurity Requirements
Health Canada released guidance for devicemakers on how to comply with premarket cybersecurity requirements. Source: The GMP Letter
Read MoreDevice Groups Reject Media Reports of Inadequate Oversight
International medical device associations rejected a recent report by the International Consortium of Investigative Journalists (ICIJ), which pointed to inadequate oversight of devices globally. Source: The GMP Letter
Read MoreFDA Unveils Guidance on Diagnostic X-Ray Equipment
The FDA issued draft guidance to clarify radiation control regulations for diagnostic x-ray systems and their major components, including recordkeeping, reporting, manufacturing, importing and installation requirements for “electronic products.” Source: The GMP Letter
Read MoreFDA Warns MiBo Medical for Design Controls, CAPAs
Seven months after issuing a Form 483 to MiBo Medical Group following an inspection of its Dallas, Texas facility, the FDA warned the devicemaker that it had not fully addressed the problems with design control procedures, CAPA procedures or complaints. Source: The GMP Letter
Read MoreJ&J in $400 Million Settlement Over Faulty Hip Replacements
Johnson & Johnson agreed to settle consumer complaints of defective artificial hips for more than $400 million. Source: The GMP Letter
Read MoreTGA Offers Guidance on Regulating Software as a Medical Device
Australia’s Therapeutic Goods Administration is reviewing how it regulates software as a medical device (SaMD) and has issued guidance on its latest thinking. Source: The GMP Letter
Read MoreFDA Partially Grants Petition for Hypnotic Drug Labeling
The FDA granted a petition to add warning labels for hypnotic drugs on the risk of injury from falling, but shot down calls for tougher risk assessments by drug sponsors. Source: Drug GMP Report
Read MoreGottlieb: FDA Will Increase Inspections of Stem Cell Facilities
The FDA will step up enforcement efforts against stem cell clinics in the coming months, Commissioner Scott Gottlieb told participants at the recent FDLI Enforcement, Litigation and Compliance Conference in Washington, D.C. Source: Drug GMP Report
Read MoreFDA Hits Connecticut Sterile Drugmaker for Mold Contamination
The FDA cited Johnson Memorial Cancer Center’s Enfield, Connecticut sterile drug manufacturing facility after investigators found sterility problems, airflow issues and mold contamination during an Oct. 1 to Oct. 19, 2018 inspection. Source: Drug GMP Report
Read MoreCanadian Drug Facility Cited for Contamination Risks
Contract drug manufacturer Jubilant HollisterStier drew a Form 483 after the FDA observed contamination risks at the firm’s Kirkland, Quebec facility. Source: Drug GMP Report
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