ISO 14971 Update Recognized by FDA, Aligned with EU MDR on Risk Management
The medical device risk management standard was updated to better align with changes in medical device regulations around the world....
Jan 20 2020,
Regulations
CMS to Remove Total Hip Replacement, Certain Spine Procedures from Inpatient Only List
Removal of these procedures from the inpatient-only list makes them eligible to be paid by Medicare in hospital outpatient and...
Dec 02 2019,
3 FDA Actions to Reduce Ethylene Oxide Sterilization
FDA has prioritized the reduction of ethylene oxide to sterilize medical devices. Recent announcements from the agency provide orthopedic manufacturers insight...
Dec 02 2019,
New Trademark Laws Stress Quality and Integrity of Registration
The United States Patent and Trademark Office has enacted policy changes to post-use audits and foreign applications. The new laws...
Nov 18 2019,
CMS Increases Medicare Physician Payment for Minimally Invasive SI Joint Fusion
Companies affected by this change include RTI Surgical, marketer of the SImmetry® system, and SI-BONE, manufacturer of the iFuse Implant...
Nov 14 2019,
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)....
Nov 04 2019,
4 Key Elements of Design Controls
Design controls require an integrated and complex process that includes inputs and outputs, reviews, verification and validation, as well as...
Nov 01 2019,
FDA Announces Advisory Panel, Releases Report on Metal Implants
FDA says gaps exist in both knowledge and the available tools that are necessary to understand and assess biological responses...
Oct 22 2019,
Process Validation Requires that You First Determine Scope
What is the current industry thinking on process validation? Our Ask the Experts series posed to the question to Carolyn...
Sep 23 2019,
Complaints and Clinical Evaluations: What Reporting Actions Should You Take?
Regulatory and quality orthopedic professionals offer advice on ways that they would manage the gray areas of complaint reporting and...
Sep 06 2019,
Computational Modeling Gets Boost from ASME Standard, FDA Science Priority
A new standard and FDA’s regulatory science priorities focus on computational modeling & simulation, which provide indication that orthopedic device...
Sep 06 2019,
3 Testing Companies Advise How to Handle Evolving Requirements
Orthopedic device companies should proactively ask FDA and other regulatory bodies about important testing requirements and changes to regulations and...
Aug 05 2019,
CMS Proposes Total Knee and Total Hip Outpatient Changes
The Center for Medicare and Medicaid Services announced its recommendation to cover total knee replacement in ASCs and total hip...
Aug 02 2019,
A Solid Quality System Will Help You Adapt to Changing Regulations
Incorporate sound quality management systems into the production of new products and processes so that regulations become guiding principles for...
Jul 22 2019,
FDA Challenges Industry to Find Sterilization Alternatives after Sterigenics, Viant Announce Facility Closures
FDA's study of new sterilization methods is in response to ethylene oxide sterilization facility closures. The closures were promoted by...
Jul 19 2019,