Medical Devices

News & Analysis as of

Health Care E-Note - August 2016

The Alabama Natural Death Act contains the provisions on how an individual may plan for end-of-life decisions. Specifically, it outlines the requirements for a valid Advanced Directive and the removal and withdrawal of life...more

Hackers Steal 600K Records from Health Care Firms – Could Your Wearable Device Be Next?

Security firm InfoArmor published a report in late July 2016 stating that a group of attackers infiltrated American health care institutions, stole at least 600,000 patient records and attempted to sell more than 3 terabytes...more

AGG Food and Drug Newsletter - August 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

Guest Post – Through the Dictionary, and What One Court Found There: Adventures in the BAAA

It’s August and several your valiant bloggers are on vacation, so the skeleton crew manning the fort is even more grateful for reinforcements than usual. Here is another guest post, this time from Reed Smith‘s Court...more

Scheduling an Appointment with Dr. Wearable Device

Fitbit, Inc. reported its quarterly results which led to an 10% increase in its share price. The company recently announced that Adam Pellegrini will join the company as Vice President of Digital Health on September 6th....more

No Idea about UDI: FDA Issues Draft Guidance on UDI Form and Content

In advance of the September compliance date for Class II medical devices, the Food and Drug Administration has issued draft guidance on the form and content of Unique Device Identifiers (UDIs). Though the UDI Rule was...more

Increase in Funding to Med Device Startups

Despite a drop in the second quarter of 2016, medical device funding is expected to finish stronger this year than in 2015. CB Insights has released a report on the funding and deal activity within the medical device...more

When Is a Software Change Really a Change that Requires FDA Review?: When to Submit a 510(k) for a Software Change to an Existing...

On the same day the Food and Drug Administration issued its revised draft guidance document on when to submit a new 510(k) premarket notification for an existing medical device, it released a similar document specific to...more

FDA Issues Draft Guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Medical Device"

On August 8, 2016, the U.S. Food and Drug Administration (FDA) issued draft guidance on the important topic of deciding when to submit a new 510(k) premarket notification application (510(k)) for a change to an existing...more

Even with a Road Map, Only One Dubious Claim Navigates Preemption

Here’s another guest post, this time from Reed Smith‘s Jaimee Farrer.  This post concerns PMA preemption, and a second opinion largely getting rid of a case that we blogged about before.  As always, Jaimee deserves all the...more

FDA Releases Revised Guidance on Device Modification Policy

FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3). The first draft...more

Well, Well, Well – What Do We Have Here: FDA Eases Up On Regulating General Wellness Products

The Food and Drug Administration has issued guidance on general wellness products, which are low risk products it will not regulate as “medical devices.” A draft of the guidance was issued in January 2015, and the final...more

DOJ Files FCA Complaint Against Recipient of Grant Funding

The FCA began as a response to procurement fraud by military contractors during the Civil War. In the intervening years, its reach has extended and increasingly the government is using the FCA as a tool in the context of...more

InSeal Medical Receives CE Mark for Vascular Closure Device

InSeal Medical recently announced that it has received CE Mark approval for its InClosure large bore vascular closure device (VCD). The InSeal VCD provides an internal biodegradable membrane for sealing large cuts in blood...more

Health Alert (Australia) August 15, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: New South Wales - 11 August 2016 - Health Care Complaints Commission v Sheldrick [2016] NSWCATOD 105 - Ms Sheldrick...more

When It’s Time to Change, You’ve Got to Rearrange: FDA Issues Draft Guidance on When Changes to an Existing Medical Device...

Many of us remember the classic 1972 Brady Bunch song, “Time to Change,” when Peter Brady sings (as his voice cracks), “When It’s Time to Change, You’ve Got to Rearrange,” channeling its inner Brady, the Food and Drug...more

FDA Finalizes Wellness Product Guidance

The Food and Drug Administration Safety Innovation Act of 2012 (“FDASIA”) required a collaborative effort by the Food and Drug Administration (“FDA”), Federal Communications Commission and Office of the National Coordinator...more

AT&T Teams Up with Biotricity to Power Wearable Medical Devices

biotricity, a medical diagnostic and consumer healthcare technology company, recently announced its partnership with AT&T, in which the internet service provider will serve as the preferred network to power biotricity’s...more

FDA Issues Proposed Guidance for Changes to Medical Device Software

The U.S. Food & Drug Administration (FDA) issued a proposed guidance on August 8, 2016, regarding software changes to medical devices. The proposed guidance relates to requirements for submitting medical device software...more

New FDA Draft Guidance on Benefit-Risk Factors Affecting Medical Device Compliance and Enforcement

In June, the U.S. Food and Drug Administration released draft guidance to clarify the benefit and risk factors it may consider in compliance and enforcement actions involving medical devices. Medical device manufacturers...more

FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices

On August 5, 2016, the US Food and Drug Administration (FDA) posted two long-awaited draft guidance documents intended to help industry and FDA staff determine whether a new premarket notification (510(k)) is required upon...more

Conflicting Defence Evidence Not Sufficient to Deny Class Certification

The Divisonal Court’s recent decision in Dine v Biomet Inc, 2016 ONSC 4039 will be of particular interest to members of the class action bar in Ontario, as it will have implications for evidence led on certification motions....more

Health Alert (Australia) August 8, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Queensland - 28 July 2016 - Beven v Brisbane Youth Service Inc [2016] QSC 163 - The plaintiff, Lindsey Beven, was...more

King & Spalding Lawyers Discuss The Regulatory Landscape At Medical Device Cybersecurity Risk Mitigation Conference

On July 25 and 26, 2016, industry stakeholders assembled in Arlington, Virginia, to participate in the Medical Device Cybersecurity Risk Mitigation Conference sponsored by Q1 Productions. The conference focused on the...more

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