FDA Applies Special Controls to Instrumentation for Certain Osteochondral Implants
FDA has ruled to classify orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into class II (special controls)....
FDA has ruled to classify orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into class II (special controls)....
Design controls require an integrated and complex process that includes inputs and outputs, reviews, verification and validation, as well as...
FDA says gaps exist in both knowledge and the available tools that are necessary to understand and assess biological responses...
What is the current industry thinking on process validation? Our Ask the Experts series posed to the question to Carolyn...
Regulatory and quality orthopedic professionals offer advice on ways that they would manage the gray areas of complaint reporting and...
A new standard and FDA’s regulatory science priorities focus on computational modeling & simulation, which provide indication that orthopedic device...
Orthopedic device companies should proactively ask FDA and other regulatory bodies about important testing requirements and changes to regulations and...
The Center for Medicare and Medicaid Services announced its recommendation to cover total knee replacement in ASCs and total hip...
Incorporate sound quality management systems into the production of new products and processes so that regulations become guiding principles for...
FDA's study of new sterilization methods is in response to ethylene oxide sterilization facility closures. The closures were promoted by...
Adhering to best practices allows engineers to work effectively within parameters of the regulations and plan projects in a way...
Utilizing FDA's Pre-Submission Process provides an opportunity to address potential concerns early in the regulatory process, and it can significantly...
FDA finalized UDI guidance for convenience kits and provided orthopedic-specific examples as context in the document....
FDA released guidance regarding the characterization of ultrahigh molecular weight polyethylene (UHMWPE) used in orthopedic devices, providing manufacturers direction in...
Today’s laser marking technology has advantages and limitations depending upon your type of orthopedic part and your budget. A Unique...
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