Regulatory Affairs

TGA Puts New Recall Procedures Into Effect

Australia’s Therapeutic Goods Administration has implemented new recall procedures that clarify when to quarantine products as well as how to communicate information about recalls. Read More

New 510(k) Pathway Could Lead to Shorter Review Times, Experts Say

The FDA’s new Safety and Performance Based Pathway for 510(k) applications should be less burdensome than the longstanding Abbreviated 510(k) route to market. Read More

Shutdown That Curtailed Some FDA Inspections Ends – For Now

The FDA reopened on January 25 following a 35-day partial shutdown of the federal government that curtailed the agency’s inspection activities that did not directly tie into public safety. Read More

FDA Unveils Safety and Performance 510(k) Pathway

The FDA released details of its Abbreviated 510(k) review process, which it has renamed the Safety and Performance Based Pathway. Read More

FDA Revises Antimicrobial Drug/Device Guidance

The FDA released revised draft guidance on coordinated development of antimicrobial drugs and antimicrobial susceptibility test (AST) devices. 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

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AdvaMed called for Health Canada to revise and clarify its draft guidance on licensing requirements for implantable devices made through 3D printing.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

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TGA Issues Draft Guidance on New UDI System

Australia’s TGA is seeking stakeholder comment on draft guidance on implementing a unique device identification system.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

FDA Lowers Risk Classification of Electroconvulsive Therapy Devices

The FDA has reclassified electroconvulsive therapy (ECT) devices that treat catatonia or severe major depressive episodes or bipolar disorder as moderate risk devices with special controls. Read More