483 Roundup: FDA Targets Firms in Israel, The Netherlands, the U.S.

The FDA flagged two overseas facilities for inadequate medical device reporting and improper handling of nonconforming products, and cited a Florida devicemaker for numerous issues observed in a July inspection. Read More

3D Printing Set to Transform Device Industry, Experts Say

3D printing is poised to transform the medical device industry, according to several players in the space who participated in a recent FDAnews webinar. Read More

Japan and Poland Sign Confidentiality Agreement in Move Toward MDSAP

Japan and Poland signed a confidentiality agreement to share regulatory information in a move that will make it easier for Poland to participate in the Medical Device Single-Audit Program. Read More

FDA Cites Devicemaker Over MDR, GMP Violations

An inspection in March by the FDA of ELITech Group’s facility in Spankeren, The Netherlands prompted a warning letter after the device manufacturer failed to follow through with the promises made in response to a Form 483 report. Read More

IMDRF Clarifies When Authorities Can Share Confidential Information

The International Medical Device Regulators Forum released final guidance that lays out procedures for sharing confidential postmarket surveillance for medical devices among regulators. Read More

483 Roundup: FDA Targets Five Devicemakers for Noncompliance

The FDA flagged device firms in the U.S., Germany, the United Kingdom, the Czech republic, and India for a range of issues, including MDR reports, CAPA failures and other GMP issues. Read More

First U.S. Surgery With 3D-Printed Implant

A custom 3D-printed composite sternum and ribcage implant was used in a surgical operation in the United States for the first time and only the second time in the world, the Australian device manufacturer Anatomics announced on Oct. 18. Read More

IMDRF Explores Using Registries to Support Regulatory Decisions

The International Medical Device Regulators Forum is inviting stakeholder comment on a draft proposal for using real-world data from patient registries in regulatory decisionmaking. Read More

483 Roundup: FDA Cites Five Firms for MDRs, Other Issues

The FDA flagged several U.S. and international facilities for a range of deviations including inadequate complaint procedures, MDR reporting, and recordkeeping. Read More

IMDRF Roundup: 3D Printing, Global Registries, SaMD

The International Medical Device Regulators Forum agreed to a new work item proposal to develop technical documents that support a harmonized approach to defining devices manufactured for individual patients. Read More