FDA Expands Inspections as Shutdown Persists
As the partial government shutdown entered a record-setting fourth week, the FDA expanded high-risk inspection activities by bringing back more unpaid staff. Read More
TGA Issues Draft Guidance on New UDI System
Australia’s TGA is seeking stakeholder comment on draft guidance on implementing a unique device identification system. Read More
Devices News
AdvaMed Suggests Health Canada Modify 3D Printing Guidance
AdvaMed called for Health Canada to revise and clarify its draft guidance on licensing requirements for implantable devices made through 3D printing. Read More
TGA Releases Draft Guidance on Device Cybersecurity
Australia’s Therapeutic Goods Administration issued draft guidance for devicemakers on cybersecurity risks. Read More
483 Roundup: FDA Flags Three Firms for MDRs, Other Violations
The FDA cited three device companies for medical device reporting, corrective and preventive actions and other violations found during inspections. Read More
IMDRF Mulls Device Single Review Program
The International Medical Device Regulators Forum is making progress in developing a medical device single review program (MDSRP). Read More
