Tag Archives: medical device

The Role of Patient Preference in Medical Device Evaluation

When we think about the top players in the medical device development space, we often see device company sponsors, clinicians, scientists, and FDA regulators as the ones driving the process. But what about the patient perspective? Does that get factored in?

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Obscure FDA Device Reporting Exemptions Draw Patient and Provider Concern

Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture.  A recent Kaiser Health News (“KHN”) article raises serious questions about FDA’s practice of allowing a significant number of medical device injury and malfunction reports to stay out of the public eye.

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FDA Finalizes Two Guidance Documents Regarding Regenerative Medicine Therapies

On February 15, 2019, the U.S. Food and Drug Administration (“FDA”) finalized two guidance documents regarding regenerative medicine therapies (see FDA’s announcement here). This development comes nearly 14 months after FDA issued both guidance documents in draft form, which also coincided with FDA’s announcement of a new comprehensive regenerative medicine policy framework intended to spur innovation and efficient access to new regenerative medicine products.

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OIG Publishes Report: FDA’s “Deficient” Cybersecurity Policies and Procedures Need Improvement

On November 1, 2018, the Office of the Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) published an audit report finding that the U.S. Food and Drug Administration’s (“FDA”) policies and procedures were “deficient for addressing medical device cybersecurity compromises.” (A copy of OIG’s complete report is available here and Report in Brief is available here.) Specifically, the OIG found that FDA’s policies and procedures were “insufficient for handling postmarket medical device cybersecurity events” and that FDA had not adequately tested its ability to respond to emergencies resulting from cybersecurity events in medical devices. Although the OIG report “did not identify evidence that FDA mismanaged or responded untimely to a reported medical device cybersecurity event,” it noted that “existing policies and procedures did not include effective practices for responding to these events.”

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CMS Unveils Proposed Rule Regarding Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products

On October 15, 2018, the Centers for Medicare and Medicaid Services (CMS) unveiled its proposed rule requiring direct-to-consumer television advertisements for prescription drug and biological products to contain the list price (defined as the Wholesale Acquisition Cost) if the product is reimbursable by Medicare or Medicaid. Medical devices are not included in the proposed rule, although CMS seeks comment on how advertised drugs should be treated if used in combination with a non-advertised device. If finalized, the requirement will be sweeping and only purports to exclude products costing under $35 per month for a 30-day supply or a typical course of treatment.

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FDA Issues Draft Guidance on Management of Cybersecurity in Medical Devices

The FDA issued a new Draft Guidance today to ensure medical devices – an increasing potential target for hackers – are better protected from unauthorized digital access.

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Accessible Medical Diagnostic Equipment Update: The U.S. Department of Veteran Affairs Will Adopt the Proposed New Standards

Earlier this month, the U.S. Access Board announced that the U.S. Department of Veteran Affairs (“VA”) will adopt the new Accessibility Standards for Medical Diagnostic Equipment.

As mentioned in our January 31, 2017, blog post, “The U.S. Access-Board Releases Long-Awaited Final Accessible Medical Diagnostic Equipment Standards,” the Access Board released its new Accessibility Standards for Medical Diagnostic Equipment (the “MDE Standards”) at the beginning of the year, with an effective date of February 8, 2017.

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ILN Today Post

Stradling Welcomes Former Head of Dorsey’s Southern California Corporate Group

(Newport Beach, CA) – Stradling Yocca Carlson & Rauth LLP announced today the addition of Parker Schweich as a shareholder in its Newport Beach office and a member of the firm’s Corporate and Securities practice group. He was previously a partner in Dorsey & Whitney’s Orange County office and head of its Southern California Corporate practice group.

“I have known Parker for more than 10 years and consider him to be an accomplished corporate attorney and a good friend,” says Mark L. Skaist, Shareholder and Co-Chair of Stradling’s Corporate and Securities practice group and a member of the firm’s Executive Committee. “We will benefit from his years of experience helping public and private companies achieve their business goals.”

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“Good Faith” Off-Label Promotions Saved Ex-Acclarent Execs from Felony Misbranding Indictments

Where does the line fall between good faith and criminal intent? That was the question that a Massachusetts federal jury faced in July as it deliberated criminal charges against William Facteau and Patrick Fabian, ex-Acclarent executives, who were indicted on multiple charges of fraud and misbranding a medical device. Acclarent’s device, the Relieva Stratus Microflow Spacer (“Stratus”), was cleared by the FDA for use as a spacer to maintain an opening in the sinus. Although the FDA expressly rejected Acclarant’s request to expand the indicated use of the device to include delivery of drugs, the government alleged that Acclarent promoted Stratus as a delivery method for the steroid drug Kenalog.

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David Waxman, Andrea Cox speak at Medmarc Medical Device Seminar

Arnstein & Lehr

David Waxman

Anrstein & Lehr

Andrea Cox

Arnstein & Lehr Chicago Partner David S. Waxman and Miami Partner Andrea Cox presented at the 26th Annual Seminar on Medical Device Claims, sponsored by Medmarc on June 13-14, 2013, at The Grand Del Mar Resort in Del Mar, California. Their presentation was titled “Joint Product Liability and Medical Malpractice Claims.”  Medmarc is a provider of insurance solutions for manufacturers and distributors of medical technology and life sciences products. Mr. Waxman and Ms. Cox are both members of Arnstein & Lehr’s Drug & Medical Device Liability Group.

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