Regulatory & Legal
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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
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Modifications to a Cleared Device: Letter to File or New 510(k)?
Change is good, right? Most orthopedic manufacturers have been working under the ISO 13485 umbrella, which stresses the need for continuous improvement. Once a device is in commercial distribution, there are valuable lessons to be learned. Shouldn&rs…Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations 05.29.18
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Doctor Charged With $240 Million Healthcare Fraud and International Money Laundering Scheme
Defendant allegedly administered chemotherapy and other toxic medications to arthritis patients based on false diagnosis.U.S. Department of Justice 05.18.18
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Spine/Neurology
SpinalCyte Applies to FDA to Expand Human Clinical Trial of CybroCell Dermal Fibroblasts
Company files investigational new drug application for degenerative disc disease cell therapy.Business Wire 05.17.18
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Biologics
FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics
The two clinics allegedly marketed products without FDA approval.PR Newswire 05.11.18
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Sterilization Breach at Colorado Hospital Put Orthopedic Patients at Risk of HIV, Hepatitis
Implant or spine surgery patients who underwent procedures between July 21, 2016, and Feb. 20, 2018 are most at risk.Colorado Department of Health & Environment 04.05.18
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Your EU Medical Devices Regulation (MDR) Questions, Answered
The upcoming EU Medical Devices Regulation (MDR) changes are significant, potentially impacting device classification and the need for clinical data. It’s imperative organizations act now to meet these requirements in 2020 and beyond. Portfolio…Nancy Morrison, Director of Regulatory Affairs, Regulatory and Quality Solutions LLC (R&Q) 03.21.18
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Biologics
Cerapedics Receives FDA IDE Approval to Initiate Study of P-15L Bone Graft for TLIF Surgery
Pivotal study to evaluate next-generation synthetic small peptide technology compared to autograft in spine surgery.Cerapedics 03.16.18
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The Impact of U.S. Regulation on Medical Device Innovation
Passion, inspiration, perseverance, altruism, and need have historically been the factors driving innovators. During World War II, antibiotics were scarce and chronic osteomyelitis and bone deficiencies such as non-unions and deformities were common.…Patricia Kontoudis, Associate, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers LLC 02.12.18
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The Use of Acceptance Criteria in a Changing Regulatory World to Support 510(k) Clearance
Successful regulatory submissions are critical for the commercialization of an orthopedic device. U.S. Food and Drug Administration (FDA) clearance on a product is not the only factor in commercial success, but it is certainly one of the key componen…Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations 02.12.18
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FDA Clears Zimmer Biomet's Sidus Stem-Free Shoulder System
System will be available in the United States beginning in the first quarter this year.Zimmer Biomet Holdings Inc. 01.05.18
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Spine/Neurology
NuVasive Extends Porous PEEK Interbody to TLIF And PLIF Procedures
Company also receives expanded FDA 510(k) clearance for COALESCE Thoracolumbar Interbody Fusion Device.PR Newswire 01.04.18
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FDA Clears Omnia Medical's PEEK-OPTIMA Vertebral Body Replacement System
Advancement was the result of a three-way collaboration between Omnia, JALEX Medical, and Invibio Biomaterial Solutions.PR Web 12.11.17
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3-D Printing/Additive Mfg.
FDA Announces 3D Printed Medical Device Guidance
World’s first agency to provide a comprehensive technical framework for 3D printed medical product manufacturing.Scott Gottlieb, M.D., Commissioner, U.S. Food and Drug Administration 12.06.17
