FDA Issues Direct Final Rule to Alter Outdated Requirements on Biologics Inspections
The rule amends that inspections will be risk-based, not biennial....
Feb 01 2018,
Regulations
UDI: Is Your System Ready for Scale?
UDI requirements have led to layers of regulatory decoding, data collection and dissemination, additional costs and moments of confusion, annoyance...
Jan 31 2018,
FDA Issues First De Novo Clearance Under Orthopaedic Panel
IlluminOss Medical recently received FDA de novo clearance for the IlluminOss Bone Stabilization System to treat pathological fractures. ...
Jan 18 2018,
The Brazilian Market: A Regulatory Overview for Orthopaedic Products
Most Brazilian surgeons use imported products, making the country attractive for international companies. Placing products on the market means creating...
Jan 05 2018,
FDA Releases Priorities for 2018
Among the Agency’s 2018 priorities is an alternative, fast-track 510(k) pathway for certain devices....
Jan 05 2018,
FDA Finalizes Additive Manufacturing Guidance
FDA published its guidance on additive manufacturing technical considerations, outlining the Agency’s long-awaited position on use of the technology for...
Dec 06 2017,
CMS Finalizes Joint Bundled Payment, Outpatient Payment Changes
The Centers for Medicare & Medicaid Services (CMS) made changes to the bundled payment model for Comprehensive Care for Joint...
Dec 06 2017,
Examining Methods to Determine Sample Sizes
Consider use of the acceptance sampling approach or the six sigma acceptable error approach to determine a sample size using...
Dec 05 2017,
Why a Well-Conceived Test Plan is Crucial to Efficient Product Development
The elements are derived from the biological, mechanical or clinical performance requirements of the device and regulatory requirements for performance...
Dec 05 2017,
Medical Device Single Audit Program Attracts Growing Interest from U.S. Companies
While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA...
Dec 04 2017,
Understanding the Critical Differences Between Supplier Audit and Evaluations
Martin Browning from EduQuest provides insight on evaluations and audits: "All of us who conduct audits recognize that most of them...
Dec 04 2017,
UDI Direct Marking Guidance Finalized by FDA
FDA did not offer device companies new direction on methods to direct mark, as it would be difficult to account...
Nov 28 2017,
Your EU Medical Device Regulation Guide
Big changes are underway for the European market and how it regulates medical devices with the recent unveiling of the...
Oct 09 2017,
CAPA Notes from an FDA Inspection
Corrective and Preventive Actions or CAPA touches nearly every process in the Quality Management System (QMS). Read insight gained by...
Oct 04 2017,
Risk Assessments: How Often Should I Update Them?
Denise Dion from EduQuest provides advice on when to update your risk documentation...
Oct 03 2017,