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June 2018

No. 461


Full Issue of The GMP Letter in PDF Format

Download and view the full issue. Read More

FDA Moves to Improve Device Safety Through Competition Around Safer Design

FDA Commissioner Scott Gottlieb offered more perspective on new initiatives the agency is undertaking to improve medical device safety in remarks at the FDLI annual conference in Washington, D.C. Read More

FDA Rejects New Device Regulation for Third-Party Servicers

The FDA rejected a push to impose additional regulations on third-party servicers of medical devices, saying there is insufficient evidence to justify imposing new regulatory requirements. Read More

Canada Makes Additional Adjustments to MDSAP Program

Health Canada is making further reductions in audit times for its Medical Device Single Audit Program for smaller companies with lower-risk products. Read More

No Regulatory Changes for Australia’s Personalized and 3D Printed Devices

Australia’s Therapeutic Goods Administration released findings from a public consultation on proposed regulatory changes for personalized and 3D printed medical devices and said, based on the stakeholder feedback, it decided not to implement regulatory changes for the devices at this time. Read More

483 Roundup: FDA Flags Six Firms Over Design Controls, Data Integrity

The FDA issued 483s to six device facilities for a variety of deficiencies including design control procedures, data integrity, CAPAs and complaint handling. Read More

India Releases Guidance on Essential Safety and Performance Principles

India’s Drugs Controller General adopted essential principles for safety and performance of medical devices. Read More

FDA Seeks Comment on Medical Device Software

The FDA invited stakeholder comments on how it should craft rules governing medical device software under the 21st Century Cures Act. Read More