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Articles Tagged "fda"

Tangible Solutions Issued No Form 483s Following FDA Inspection

by BONEZONE | Apr 2019

The inspection reviewed additive manufacturing equipment validations and records, as well as other controls and procedures.   ... Read more »

FDA Targets Device Materials, Releases Metal-on-Metal Study Results

by BONEZONE | Apr 2019

FDA is looking at materials used in medical devices, citing growing evidence that a small number of patients may have adverse biological responses to certain types of materials. As the agency rolls out new guidance, orthopedic manufacturers should expect greater scrutiny of materials during pre... Read more »

FDA Proposes Framework for Artificial Intelligence-Based Devices

by BONEZONE | Apr 2019

Artificial intelligence technology is evolving quickly, and the potential benefits of adaptive AI systems in relation to modern medicine are seemingly endless. FDA plans to establish a new regulatory framework for medical devices that use advanced AI algorithms.   ... Read more »

Zimmer Biomet Gains FDA Clearance of ROSA ONE Spine System

by BONEZONE | Apr 2019

The company now has FDA 510(k) clearance for knee, spine and brain applications on one robotic platform. ROSA SPINE features dynamic tracking that allows it to move with the patient, supporting accuracy without the need to be attached to the patient or the surgical table.   ... Read more »

CurvaFix Receives FDA 510(k) Clearance for CurvaFix Rodscrew

by BONEZONE | Mar 2019

CurvaFix is developing implantable products to improve bone repair following serious fracture and injury. This is the company’s first product, and first FDA 510(k) clearance.     ... Read more »

FDA 510(k) Recap: AQrate, ROSA and First Clearances

by BONEZONE | Feb 2019

In January, Globus Medical and Zimmer Biomet received key robotic FDA 510(k) clearances, while five companies within the spine, sports medicine and trauma markets received their first clearances.       ... Read more »

FDA 510(k) Recap: Companies Gaining First Clearances in 2018 and 2019

by BONEZONE | Jan 2019

Products highlighted here — representing the spine, joint reconstruction, trauma and arthroscopy/soft tissue segments — include a total hip, cervical plate, interbody fusion system, lumbar fusion system, spacer, pedicle screw systems and more. ... Read more »

FDA Works to Modernize 510(k) Process, Takes Aim at Predicates, De Novo Pathways

by BONEZONE | Jan 2019

This more modern 510(k) pathway is to be used for clearance of low- to moderate-risk devices. It has a focus on predicate devices that are 10 years old or less, and its framework is aimed at efficiently advancing beneficial technology to patients while keeping with FDA’s standards for safety and e... Read more »

Most Popular Articles of 2018 Featured Robotics, Contract Manufacturer M&A

by BONEZONE | Jan 2019

What else did you read about the most on our website last year? Arthroscopy/soft tissues companies to watch; products in spine, knee and hip; surgeon perspectives on implant material choice; supply chain quality; labelling mistakes, Brazil and more. ... Read more »

Cobalt Chrome Additive Total Knee Successfully Tested by Italian Startup

by BONEZONE | Dec 2018

Rejoint's EBM additively-manufactured cobalt chrome YourKnee™ —which utilizes pre- and intra-op computer assisted technology, wearables, artificial intelligence and surgical simulation— achieved a first complete mechanical test. First surgery is slated for 1Q19 in Italy. Limited launch is... Read more »

OEMs Continue Focus on Reducing Instruments in Operating Rooms

by BONEZONE | Oct 2018

Several device companies within the last two years have capitalized on the shift toward simpler surgeries with fewer instruments in the forms of recent product launches or revisions, process initiatives and 510(k) clearances.... Read more »

Crucial Validation Considerations for Instrument Cases and Trays

by BONEZONE | Oct 2018

Common challenges device company engineers face during validation of delivery systems include case/tray longevity, robustness of design, maintaining integrity of ID markings and establishment of worst-case testing parameters. ... Read more »

b-ONE Ortho Gains FDA 510(k) Clearance for Total Hip

by BONEZONE | Sep 2018

The b-ONE™ cementless total hip system is the company’s first product following a US $20.0MM round of Series A financing.... Read more »

Think Different About Management Reviews

by BONEZONE | Jun 2018

When done correctly—with preparation and an energized approach—these reviews can complement strategic planning and measure the effectiveness of your QMS in relation to your business model.... Read more »

FDA Clears Artificial Intelligence Software for Wrist Fractures

by BONEZONE | Jun 2018

Medical imaging diagnostic group Imagen Technologies created OsteoDetect software, which identifies fractures in x-rays using an AI algorithm to analyze images.... Read more »

Why the Inadvertent Release of Non-Conforming Products is Reportable, Recordable

by BONEZONE | May 2018

It is recommended to err on the side of caution in these situations and report the product release, as well as record any internal corrections.... Read more »

FDA Issues Direct Final Rule to Alter Outdated Requirements on Biologics Inspections

by BONEZONE | Feb 2018

The rule amends that inspections will be risk-based, not biennial.... Read more »

FDA Releases Priorities for 2018

by BONEZONE | Jan 2018

Among the Agency’s 2018 priorities is an alternative, fast-track 510(k) pathway for certain devices.... Read more »

Examining Methods to Determine Sample Sizes

by BONEZONE | Dec 2017

Consider use of the acceptance sampling approach or the six sigma acceptable error approach to determine a sample size using statistics.  ... Read more »

Medical Device Single Audit Program Attracts Growing Interest from U.S. Companies

by BONEZONE | Dec 2017

While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA named it an official program earlier in 2017.   ... Read more »

Understanding the Critical Differences Between Supplier Audit and Evaluations

by BONEZONE | Dec 2017

Martin Browning from EduQuest provides insight on evaluations and audits: "All of us who conduct audits recognize that most of them are nothing more than snapshots in time. In contrast, an evaluation gathers and analyzes data from all kinds of sources, without physical constraints associat... Read more »

UDI Direct Marking Guidance Finalized by FDA

by BONEZONE | Nov 2017

FDA did not offer device companies new direction on methods to direct mark, as it would be difficult to account for the wide variety of existing devices, use conditions and reprocessing methods.... Read more »

The Fused and the Fractured: New Entrants to U.S. Spine and Trauma

by Julie Vetalice | Aug 2017

Globus Medical has received clearance for its first two trauma products. While they prepare to enter that space, numerous competitors are bringing out interbody fusion devices for introduction in U.S.   ... Read more »

Trauma and Spine Gain New Players with First 510(k)s in 1H17

by BONEZONE | Aug 2017

In 1H17, 23 orthopaedic companies from 11 countries received their first 510(k), according to our scan of FDA’s database. Nine of the 23 510(k)s were in trauma and seven in spine.... Read more »

FDA Releases Final Guidance on Human Factors and Usability Engineering

by BONEZONE | Apr 2016

The Agency released the final guidance on considerations for human factors data in premarket submissions, as well as two draft guidances on the topic.... Read more »

8 Design Control Issues Found During FDA Inspections

by John Gagliardi | Nov 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | May 2015

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. An asterisk denotes those receiving their first clearance for an orthopaedic product.... Read more »

FDA Addresses Custom Device Exemptions

by Hannah Corcoran | Nov 2014

FDA clarified changes to the Custom Device Exemption provision through a final guidance document.... Read more »

BONEZONE Authors Present Solutions at OMTEC 2013

by BONEZONE | Apr 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Recognizes Computer Simulated Performance Data in Device Evaluation

by BONEZONE | Apr 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Get Ready for UDI: It’s All About the Data

by BONEZONE | Mar 2013

Orthopaedic OEMs will be among the first to comply with FDA's unique device identification requirements once finalized. However, the complex nature of UDI means OEMs can’t wait for the final announcement to put processes in place.... Read more »

Lessons Learned From Metal-on-Metal Implants

by Robert Packard | Mar 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Releases New Requirements for Combination Products

by BONEZONE | Mar 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

ASTM Names New Standard for Raw Materials

by BONEZONE | Mar 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Hammill Manufacturing Completes Recent FDA Inspection

by BONEZONE | Feb 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Jan 2013

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: B2B Spine, Brainlab, Christopher D. Endara, Emerge Medical, Everest Spine, Fairway Medical, Foundry (Newco XI), Frontier Medical, InSurgical, NCS Lab, Ouroboros Medical, Stabiliz Orthopaedics, Z-Medic... Read more »

Making Smarter Product Recall Decisions: 4 Critical Steps to Meeting FDA’s Expectations

by Martin Browning | Dec 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Blogs and Apps that Bring Solutions

by BONEZONE | Dec 2012

UPDATE: Mr. Packard's blog has moved to Medical Device Academy. Also, find his BONEZONE articles  by clicking on the author tab on the homepage. Quality Control can be stale. Reading about it can be even duller. Rob Packard wants to change that by bringing the topic to life with his blog, QC i... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2012

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space: Alliance Spine, Aston Medical, Iconacy Orthopedic, Implanet, Intelligent Implant Systems, Osseon Therapeutics, Providence Medical, Safe Orthopaedics, Shanghai Kinetic, Shoulder Options, Weigao Orthopa... Read more »

Medical Metrics Selected as Imaging Core Lab for Multiple FDA Metal-on-Metal Hip Studies

by BONEZONE | Dec 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Ceram Launches Regulatory Approval Package

by BONEZONE | Oct 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Draft Guidance: Refuse to Accept 510(k) Policy

by BONEZONE | Oct 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Oct 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Unique Device Identification: From Compliance to Value

by BONEZONE | Oct 2012

It took five years, but the U.S. FDA has finally issued the proposed Unique Device Identification rule that will require manufacturers of medical devices to uniquely identify their products and populate FDA’s global UDI database. Orthopaedic manufacturers will be among the first impacted... Read more »

FDA to Guide Device Makers on Marketing Application

by BONEZONE | Aug 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Aug 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Building a Basic Good Clinical Practice Foundation to Weather the Storm

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Histogenics Selects ImageIQ to Provide Imaging Analysis for Phase 3 Clinical Trial

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA - The Fly in the Ointment - OMTEC 2012 Opening Panel Discussion

by BONEZONE | Jul 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The Anatomy of a Warning Letter, Part Two: Excerpts and Response Strategies

by John Gagliardi | Jun 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Metal-on-Metal Hips in the News

by BONEZONE | Jun 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Jun 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Daily Documentation Essentials: A Tour of the Regulatory Binder

The road to market approval for orthopaedic devices can be long and arduous, but it is impossible without valid data. Regulations governing practices in clinical research demand the highest level of ethical and clinical standards, with patient protection as the highest priority. Historical precedent... Read more »

FDA and industry reach agreement in principle on medical device user fees

by BONEZONE | Mar 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The Anatomy of a Warning Letter, Part One: A Primer

by John Gagliardi | Mar 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Mar 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

510(k) Clinical Data Requirements: Current Status and Considerations for Clinical Studies

by BONEZONE | Mar 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2011

The following companies recently received strategic FDA 510(k) clearances for devices in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Algea TherapiesAffirm Vertebral Compression Fracture System... Read more »

The CMS/FDA Proposed Parallel Review Process: Can One Clinical Trial Really Satisfy Two Agencies?

by BONEZONE | Sep 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The View from Washington: What Device Makers Need to Know about FDA’s Latest Strategic Priorities and Initiatives

by BONEZONE | Aug 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The Internal Quality Audit Process for Orthopaedic Medical Device Companies: Risk Indicators and Uncertainties

by BONEZONE | Aug 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Blogs and Apps That Bring Solutions

by BONEZONE | Jun 2011

  InVivoLink Introduces OrthoPod, a Tablet-based Implant Registry Application;  Emergo Group Medical Device Blog for QA/RA Professionals;  IMARC Research Blog... Read more »

Corrective and Preventive Action: What Does FDA Look For During Inspection?

by BONEZONE | Mar 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Review of Study Results: FDA Impact on U.S. Medical Technology Innovation

by BONEZONE | Dec 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

MDD Regulations: What I Wish I Had Known

by BONEZONE | Sep 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »