News & Analysis as of

Medical Devices The United States Food and Drug Administration

Congressional Committees Advance Bipartisan FDA User Fee Agreements

by Baker Donelson on

On May 11 and June 7, the Senate HELP Committee and House Energy and Commerce Committee, respectively, both advanced bipartisan legislation to reauthorize four different user fee agreements that account for over a quarter of...more

FDA Requires Reprocessing Validation Data for Certain Reusable Devices

by Hogan Lovells on

On June 9, 2017, the U.S. Food and Drug Administration (“FDA”) published a Federal Register Notice announcing that new 510(k) notices for a number of reusable medical devices will now require the support of validated...more

FDA Commissioner Forecasts New, Modernized Digital Health Regulatory Framework

by Ropes & Gray LLP on

In his first public statement as Commissioner of the Food and Drug Administration (“FDA”) on the regulation of digital health technologies, Scott Gottlieb, M.D., signaled that FDA is contemplating significant changes. In a...more

Gottlieb Announces New Regulatory Paradigm for Digital Health Software

by Hogan Lovells on

Recognizing both the opportunities and the potential regulatory challenges presented by such rapid development, the FDA – under the leadership of recently confirmed Commissioner Dr. Scott Gottlieb – is spearheading a new...more

Medtronic's Recent Interactions with the FDA

by Knobbe Martens on

It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency. Below is a brief summary of some recent of...more

House Energy & Commerce Committee Unanimously Approves FDA Reauthorization, Public Health Bills

by Reed Smith on

On June 8, 2017, the Energy and Commerce Committee voted unanimously to approve an amended version of HR 2430, the FDA Reauthorization Act (FDARA) of 2017. The bill would extend the FDA prescription drug, medical device,...more

To certify or not to certify? FDA has answered the question

by Hogan Lovells on

On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors  should submit Form FDA 3674...more

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

by Hogan Lovells on

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device...more

FDA Extends Unique Device Identification (UDI) System Compliance Deadlines for Certain Low-Risk Medical Devices

by McDermott Will & Emery on

In Depth - On June 2, 2017, the US Food and Drug Administration (FDA) announced that it plans to delay the dates by which certain Class I devices and unclassified devices must comply with the agency’s unique device...more

As FDA Ramps Up Digital Health Program, BakerHostetler Hosts a Medical Device Connectivity Webinar Addressing Digital Technology...

by BakerHostetler on

Recent reports indicate that Food and Drug Administration (FDA) plans to build a digital health unit within and assign a number of digital scientists to the Center for Devices and Radiological Health. The digital health unit...more

Effective Immediately: The FDA Updates Humanitarian Device Exemption Regulations

by Faegre Baker Daniels on

On June 7, the U.S. Food & Drug Administration (FDA) announced that it is updating the humanitarian device exemption (HDE) regulations. The changes are meant to bring the regulations into compliance with the 21st Century...more

FDA Extends the UDI Compliance Date for Certain Class I and Unclassified Devices

With the deadline for compliance with the unique device identification system[i] (UDI system) requirements for certain Cass I and unclassified devices other than implantable, life-supporting, or life-sustaining devices (i.e.,...more

Filling in the Gaps on Medical Device Cybersecurity

by Hogan Lovells on

Cybersecurity has become a hot button topic for many in the medical device industry following the announcement of several high-profile medical device vulnerabilities and in light of the recent WannaCry ransomware attack that...more

Part III: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

This post, Part III, of a three-part series on FDA’s interchangeability draft guidance highlights a number of open issues that stakeholders have identified in their comments to FDA....more

FDA Begins Reorganization that Will Affect How it Regulates Medical Technology

by Hogan Lovells on

What impact will the U.S. Food and Drug Administration’s significant reorganization efforts have on how the agency regulates medical technology? The agency is reorganizing the Office of Regulatory Affairs (ORA) and combining...more

[Webinar] Medical Device Connectivity: HIPAA, FDA and IP Considerations - June 14th, 2pm ET

by BakerHostetler on

Please join us for this complimentary CLE webinar. With increasing healthcare costs and the transition to value-based reimbursement, never has the need for connected medical devices been so great – and never have the...more

The Life Sciences Report - Summer 2017

Factoring in Human Factors - According to a recent British Medical Journal research report, the mean rate of death from medical error in U.S. hospitals is estimated to be over 251,000 people per year. Though many medical...more

Part I: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017. Innovators, biosimilar makers, patients, healthcare providers and other...more

AGG Food and Drug Newsletter - May 2017

by Arnall Golden Gregory LLP on

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

Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

by Pepper Hamilton LLP on

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation

by Hogan Lovells on

Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934), by a vote of 21–2. Please see full...more

Confirm Rx: Abbott Receives CE Mark for Smartphone Compatible ICM

by Knobbe Martens on

Abbott recently announced the CE Mark and first use of what it claims is “the world’s first smartphone compatible” insertable cardiac monitor (ICM), as reported by a press release dated May 8, 2017....more

Ransomware Imminently Expected to Target Medical Devices

by Baker Donelson on

As a wave of devastating ransomware-based attacks spread across the globe last week, it became abundantly clear that the medical industry at large was ill-prepared for the threat despite years of warnings. The virus hit...more

No Ifs, Ands Or Butts – Preemption Gutts, Rebutts, and Shutts Down Utts

by Reed Smith on

Late last year we happily blogged about Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2016 WL 7429449 (S.D.N.Y. Dec. 23, 2016), chiefly because it held that design defect claims against a branded prescription drug...more

FDA User Fee Legislation Moves Forward in Senate with Multiple Policy Riders On-Board

On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934. The committee...more

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