Regulatory & Legal
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Spine/Neurology
Dismissal Stipulation Filed in Boston Scientific, Nevro Patent Case
The California case has now ended, with Nevro receiving none of its requested relief.PR Newswire 12.15.20
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13 Mistakes to Avoid in a 510k Submission
The FDA 510(k) review process can broadly be divided into two steps—acceptance review and substantive review.Samradni Patil, Regulatory Consultant and Writer, Kolabtree 11.18.20
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Medical Device Equivalence Requirements Strengthened under the EU MDR
This column focuses on the directive under EU 2017/745 on medical devices (MDR), highlighting some of the changes in claiming and demonstrating equivalence.Cindy Boyer, Senior Manager, International Regulatory Affairs, MCRA LLC 11.18.20
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Solid Footing During Shaky Times: Current Compliance Considerations
The changes and challenges wrought by COVID-19 have significantly impacted the medtech industry.Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 11.18.20
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MedShape Given Unique ICD-10-PCS Codes for Sustained Compression Internal Fixation Device
NiTiNOL-based DynaNail products approved for use with new code.PR Newswire 10.14.20
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When to Submit a 510(k)
When are design and manufacturing changes considered significant enough to surpass the threshold of submitting a new 510(k)?Tom McDougal, MS, Associate, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers LLC 09.15.20
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Spine/Neurology
FTC to Refund NeuroMetrix Customers $3.9M in False Advertising Case
FTC said the defendants lacked scientific evidence to support widespread chronic pain-relief claims.Federal Trade Commission 09.09.20
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Recent Regulatory Changes and a 2020 Election Update
Legislators in Washington are keenly focused on both the upcoming national election on Nov. 3 and addressing the healthcare challenges during a pandemic.Jeffrey J. Kimbell, David C. Rudloff, Caroline P. Tucker and Matteson L. Beckis, Jeffrey J. Kimbell & Associates Inc. 08.11.20
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AAOS Alarmed by CMS Proposal to Reduce Orthopedic Surgical Services
CMS also is considering reducing the work relative value units for hip and knee arthroplasty by an additional 5.4 percent.American Academy of Orthopaedic Surgeons 08.05.20
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Spine/Neurology
AgNovos Healthcare Receives Breakthrough Designation for Spine Device
The company's kit is intended to minimally-invasively treat painful but stable vertebral compression fractures.Business Wire 06.08.20
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Large Joint
Conformis, Zimmer Biomet Settle Patent Dispute Over Patient-Specific Instruments
The patents in question were related to instruments used with off-the-shelf knee, hip, and shoulder implants.Conformis Inc. 05.28.20
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Biocompatibility & Testing
Conducting Chemical Characterization/Risk Assessment for FDA Submissions
Chemical characterization/risk assessment is a powerful methodology for addressing select biocompatibility endpoints.Robert A. Allen, Ph.D., Senior Associate, Regulatory Affairs, MCRA LLC 05.20.20
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COVID Strategy for Regulatory and Quality Professionals and Their Leaders
...Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 05.20.20
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MDR Delay Official; Industry Urges Push Back of IVDR
European Council voted 27-0 to adopt amendment delaying MDR application by one year due to COVID-19 pandemic.MedTech Europe 04.24.20
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EU’s Parliament Adopts MDR Delay of One Year
Allows authorities and manufacturers to prioritize the fight against COVID-19.European Parliament 04.17.20
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Adopted Proposal Would Delay MDR One Year
The proposal would need the full support of the European Parliament and the Council through an accelerated co-decision procedure.European Commission 04.03.20
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FDA Suspends Foreign Inspections
The agency has postponed most foreign inspections through April, effective immediately.Food and Drug Administration 03.10.20
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Spine/Neurology
SpineFrontier Sued Over Alleged Kickbacks to Surgeons
Defendants allegedly paid spine surgeons over $8 million in sham “consulting” payments.United States Department of Justice 03.06.20
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Spine/Neurology
Stimwave, Nevro Settle Patent Suit
Stimwave will cease commercialization of all high-frequency spinal cord stimulation systems.Business Wire 02.28.20
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FDA Offers Coronavirus Update Regarding Product Safety
The agency outlines the steps it will take to ensure the quality of foreign products.U.S. Food and Drug Administration 02.25.20
