Regulatory & Legal
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Reworked Tax Relief Package Could Delay Medical Device Tax Five More Years
The House Ways and Means Committee introduced the legislation in response to urgent relief from recent natural disasters.Sam Brusco, Associate Editor 12.11.18
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Large Joint
Past Dues: A Review of Industry in 2018
The industry confronted old ghosts in 2018 as it defended itself against a documentary and crammed for regulatory changes.Michael Barbella, Managing Editor 11.30.18
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MDSAP Audits Update: Progress, Challenges, and a Cost Reduction Case Study
The Medical Device Single Audit Program (MDSAP) is growing fast, with 3,629 sites now participating, as compared to just 788 at the end of 2017. Part of this explosive growth stems from the fact that Canada will require manufacturers to comply wit…Anthony Parise, Product Strategist—Life Sciences, ETQ 11.30.18
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Data Monitoring Committees: Making DMCs Work for Your Study
The use of independent data monitoring committees is becoming increasingly prevalent in the U.S. medtech industry. The FDA outlines these groups and their operation in a 12-year-old guidance due to expire at the end of this year. However, the composi…Margeaux Rogers, Senior Associate, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers LLC 11.30.18
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Top 10 Findings from a Warning Letter Analysis
When I first started out in medtech, I did not have a good appreciation for quality systems. I was working as an engineer at the time, and I found quality systems quite a nuisance because any change I proposed was either restricted or not allowed due…Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations 11.30.18
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Spine/Neurology
Zimmer Biomet Recalls Spinal Fusion and Long Bone Stimulators
Certain lots were recalled due to lack of adequate validation and controls to ensure product cleanliness.U.S. Food and Drug Administration 11.29.18
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FDA Plans to Modernize 510(k) Program
Agency releases statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., director of the CDRH.U.S. Food and Drug Administration 11.26.18
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Spine/Neurology
Zimmer Biomet Spine Announces FDA Approval of Mobi-C Cervical Disc Labeling Extension
Seven-year results demonstrate clinical superiority of Mobi-C two-level cervical total disc replacement procedures.Zimmer Biomet Holdings Inc. 09.28.18
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Getting Started on the Right Foot: Initiating Orthopedic Clinical Trials
Initiating an orthopedic clinical trial (OCT) is an exciting milestone for companies as years of pre-clinical testing and conversations with the U.S. Food and Drug Administration (FDA) finally come to fruition. Focusing on specific elements of the st…Bhavana Shivakumar , Clinical Research Associate, Musculoskeletal Clinical Regulatory Advisers LLC 09.19.18
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Large Joint
Conformis Settles Patent Dispute With Smith & Nephew
Conformis to receive $10.5 million for non-exclusive license to patient-specific instrument patents.Globe Newswire 09.17.18
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IlluminOss Medical Receives Clearance to Expand Clinical Indications in the U.S.
Secures FDA clearance for the treatment of traumatic, fragility, pathological, and impending fractures.Globe Newswire 09.13.18
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Acantha Wins $8.2 Million Patent Infringement Verdict Against DePuy Synthes
The patent in question covered an orthopedic implant assembly used to join bone segments.PR Newswire 08.24.18
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Extremities
KFx Medical Sues Stryker for Rotator Cuff Repair Patent Infringement
KFx successfully defended these patents versus Arthrex Inc. in 2015.Business Wire 08.17.18
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Effects of MEDDEV Revision 4 on Clinical Evaluation Reports (Part 2)
Whether writing a clinical evaluation report (CER) for a new device or updating one for an existing device, compliance with MEDDEV 2.7/1 Revision 4 requirements is integral. As part of the general planning associated with CERs, first perform a gap as…Jonathan Gimbel, Director, Regulatory and Quality Solutions LLC (R&Q) 08.15.18
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Innovation in the 510(k) Space: A Case for Incrementalism
Although the term “innovative technology” often evokes images of a breakthrough, radical discovery, or inventive cure-all, the certainty associated with incremental improvements to established, higher-risk technologies such as implantable…Samuel Pollard, Senior Regulatory Associate, Musculoskeletal Clinical Regulatory Advisors 08.15.18
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FDA’s Educational Opportunities Abound
As a former U.S. Food and Drug Administration (FDA) reviewer, I have spent a considerable amount of time learning the system from the “inside.” There are many avenues of training offered by the FDA, and if you know where to look, you may…Elizabeth O’Keeffe, Ph.D., Director, Engineering and Technical Services, Secure BioMed Evaluations 08.15.18
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Contract Manufacturing | Machining & Tooling
Empirical Machine Earns FDA Contract Manufacturer Designation
Colorado Springs company approved to craft medical devices in addition to prototyping, small-batch manufacturing.Empirical 06.14.18
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Extremities | Large Joint | Spine/Neurology | Trauma/Sports
FDA Initiates Device Development Challenge to Help Combat Opioid Crisis
The agency will work closely with selected applicants to accelerate product development.U.S. Food and Drug Administration 05.31.18
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Effects of MEDDEV Revision 4 on Clinical Evaluation Reports (Part 1)
The latest revision of MEDDEV 2.7/1 was published June 2016 and calls for substantial changes from revision 3. Updating clinical evaluation reports (CER) to meet the new requirements will require a major effort for most manufacturers selling in the E…Jonathan Gimbel, Director, Regulatory and Quality Solutions LLC (R&Q) 05.29.18
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Design | Research & Development
The Hidden Costs of Clinical Trial Agreement Negotiations
Negotiating can be a daunting task, often inducing anxiety in those without much practice. For many, it’s not a skill that develops naturally or easily. Graduate programs offer numerous courses aimed at preparing students for the necessary evil…Megan Florez, Compliance and Reimbursement Associate, Musculoskeletal Clinical Regulatory Advisors 05.29.18
