Regulatory & Legal

When Is Digital Health Technology Regulated?

Whether you’re a startup or a well-established manufacturer, it can be challenging to determine if the software you’re developing needs FDA oversight.

Nikki Batista, Director, Digital Health Regulatory Affairs, MCRA LLC 05.17.21

Spine/Neurology

Life Spine Wins Second Ruling Against Aegis Spine

Bars Aegis from marketing, selling, or distributing its AccelFix-XT devices

Sam Brusco 05.07.21

A Summary of Key Provisions Within CMS’ Final MCIT Rule

MCIT is available not only for new breakthrough devices but also for products that received this designation within the last two years.

John D. McDermott Jr., Senior Director, Reimbursement Strategy, MCRA LLC 03.16.21

Hyaluronic Acid: Drug or Device?

In December 2018, the agency issued a Notice in the Federal Register that it was considering a change in how HA was classified.

Sean Fenske, Editor-in-Chief 03.16.21

Biologics

Medtech Matters: FDA’s Ambiguity on Hyaluronic Acid

MPO's Sean Fenske speaks with Mike Daley of OrthogenRx about the role HA plays in alleviating knee pain and the challenges with the FDA over it.

Sean Fenske, Editor-in-Chief 03.02.21

Tips for Reigniting Your MDR/IVDR Preparation

To get the MDR/IVDR preparation ball rolling again, here are four processes to help refocus on achieving compliance with the updated regulations.

Nicolle Cannon, Founder and CEO, Cannon Quality Group LLC 02.08.21

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

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

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

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

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

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

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

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