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Best Practices Medical Devices

Gardner Law

Change Control Pitfalls: Legal & Regulatory Risks in FDA-Regulated Industries

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Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more

Hendershot Cowart P.C.

Qlarant, Novitas Audits Escalate as Medicare Skin Substitutes Spending Hits $1.6 Billion, CMS Seeks Evidence of Clinical...

Hendershot Cowart P.C. on

The wound care industry faces unprecedented scrutiny as Medicare Part B expenditures for skin substitutes exceeded $1.6 billion in the fourth quarter of 2023 alone. The spending surge has triggered a wave of skin substitute...more

Mintz - Health Care Viewpoints

Health Law Diagnosed – Best Practices for Communicating with the FDA

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA....more

Mintz

[Podcast] Health Law Diagnosed – Best Practices for Communicating with the FDA

Mintz on

In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA. Hear from Joanne Hawana and Ben Zegarelli, FDA specialists...more

Benesch

Updates to Ohio State Dental Board’s Position Statement on Treatment of Sleep-Disordered Breathing

Benesch on

Summary The Ohio State Dental Board (the “Board”) recently updated its position statement, “Role of the Dentist in the Treatment of Sleep-disordered Breathing.” ...more

Arnall Golden Gregory LLP

[Webinar] Mitigating the Impact of Tariffs: A Practical Guide for Life Sciences Companies - June 17th, 12:00 pm - 1:00 pm EDT

AGG partner and Life Science team member, Allison Raley, will present a complimentary webinar examining how life sciences companies can overcome challenges in the face of U.S. tariffs. As international trade tensions persist...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, Heather and Matthew welcome back a favorite friend of the podcast, Laura Gunter, President of NCLifeSci. We discuss the highlights of the 2024 Annual Meeting such as...more

Foley & Lardner LLP

Artificial Intelligence in Health Care: Key Considerations for Oncology

Foley & Lardner LLP on

Artificial intelligence (AI) has the power to revolutionize health care. In oncology, there are now opportunities to apply AI to support diagnostics, predictive analytics, and administrative functions. This hot topic was...more

Wilson Sonsini Goodrich & Rosati

[Event] Medical Device Digital Health Conference - June 13th - 14th, San Francisco, CA

Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

Epstein Becker & Green

Unpacking Averages: Analyzing FDA’s Performance in Finalizing Guidance Documents

FDA’s January 3, 2024, Federal Register notice soliciting comments on the agency’s plan to implement best practices for guidance development got me thinking.  What do the data show regarding FDA’s performance in moving...more

Health Care Compliance Association (HCCA)

Transparency and the Open Payments Program

To quote CMS, “The Open Payments program is a national disclosure program that promotes a more transparent and accountable health care system. Open Payments houses a publicly accessible database of payments that reporting...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 5th - 6th, New York, NY

Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more

ArentFox Schiff

FDA Issues Draft Guidance on Best Practices for Selecting Predicate Devices for 510(k) Notifications

ArentFox Schiff on

The US Food and Drug Administration (FDA) has just issued a draft guidance entitled “Best Practices for Selecting a Predicate Device to Support a Premarket Notification 510(k) Notification.” This draft guidance is one of...more

American Conference Institute (ACI)

[Event] 18th Annual FCPA & Anti-Corruption for the Life Sciences Industry - May 10th - 11th, New York, NY

Hosted by American Conference Institute, the 18th Annual Conference on the FCPA & Anti-Corruption for the Life Sciences Industry returns for another exciting year with curated programming that shines a global spotlight on...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Goodwin

Patient Stakeholder Group Zeroes in on Medical Device Industry

Goodwin on

In recent months, the Kaiser Health Network (part of the Kaiser Family Foundation) has issued three reports scrutinizing the orthopedic industry and its practices. Each report articulates the stakeholder group’s concerns over...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Research Compliance Conference - June 14th - 16th, 9:00 am - 5:00 pm CDT

Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more

Butler Snow LLP

The Case for Non-Retained Expert Witnesses

Butler Snow LLP on

It’s not easy getting a drug or device to market. From concept to launch, it takes years of work and the involvement of countless professionals from the engineering, medicine and regulatory disciplines. If the product becomes...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Winter 2021

The firm is pleased to present the latest edition of The Life Sciences Report. This issue features a sampling of recent COVID-19-related client activity in which the firm has been involved, an article on life sciences venture...more

American Conference Institute (ACI)

[Virtual Event] 25th Annual Conference on Drug & Medical Device Litigation - December 8th - 9th, 8:45 am - 5:45 pm EST

Join us as we celebrate the 25th Anniversary of ACI’s Annual Flagship Conference on Drug & Medical Device Litigation! ACI’s Drug and Medical Device Litigation has united the greatest minds of the pharmaceutical and medical...more

Nossaman LLP

Health Care Providers’ Crisis Care Guidelines in Light of Recent OCR and CDPH Guidance

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Faced with an ongoing public health emergency that threatens to overload healthcare systems, many states, including California, have developed or revisited their crisis care guidelines to address a potential COVID-19 patient...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Patent Prosecution Tool Kit: Medical Device Considerations

Preparing and prosecuting medical device patents can be unique and challenging. Patent owners and practitioners often must consider a wide range of converging technologies from the mechanical, electrical, chemical, and...more

McDermott Will & Emery

FDA Update: Enforcement Policies for Gowns, Gloves, Sterilizers, Disinfectant Devices and Air Purifiers

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In response to growing medical product supply shortages and need for information, the US Food and Drug Administration (FDA) has recently issued multiple enforcement policies to provide guidance to industry. Here, we focus on...more

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