News & Analysis as of

Final Guidance

FDA Finalizes De Novo Evaluation Guidance and Issues Associated Refuse to Accept Checklist

by Hogan Lovells on

On October 30, 2017, the Food and Drug Administration (FDA or the Agency) released its final De Novo request guidance document entitled, De Novo Classification Process (Evaluation of Automatic Class III Designation) (Final...more

FDA Issues Guidance on Submitting 510(k)s for Changes to Existing Devices

by Arnall Golden Gregory LLP on

On October 25, 2017, the Food and Drug Administration (FDA) issued a final guidance document, Deciding When to Submit a 510(k) for a Change to an Existing Device, which describes when a change in a medical device would...more

Final EU Guidelines on Information Required for Authorization Applications by Payment Institutions

by Shearman & Sterling LLP on

The European Banking Authority has published final Guidelines on the information to be provided for the authorization of payment institutions and electronic money institutions, and for the registration of account information...more

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

Recently, the U.S. Food and Drug Administration (FDA) issued final guidance on deciding when to submit a new 510(k) premarket notification application for a change to an existing medical device. The guidance is far reaching...more

FDA Issues Long-Awaited Final Guidance on When a Device Modification Requires a New 510(k)

by Hogan Lovells on

Six years after its first attempt to update its now 20-year-old guidelines for when modifications to a 510(k)-cleared device require the submission of a new 510(k) notice, the U.S. Food and Drug Administration (FDA or the...more

Is it a drug, device, biologic, or combination product? FDA issues final guidance on classification

by Hogan Lovells on

On September 26, 2017, the Food and Drug Administration (FDA) published a final guidance document providing further clarity on how FDA classifies a product as a drug, device, biological product, or a combination product,...more

Building a Health App? Part 3: What You Need to Know About FDA’s Regulation of Mobile Apps

This is our third installment in our series about the legal issues involved in launching a health app, which the U.S. Food and Drug Administration (“FDA”) refers to as “mobile apps.” The goal of this post is to provide you...more

Working Together: FDA Releases Final Guidance on Interoperability

by Hogan Lovells on

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more

FDA Issues Final Drug and Device Classification Guidance

by McDermott Will & Emery on

This week, the FDA published final guidance outlining the agency’s current thinking with respect to the classification of products as drugs or devices, respectively. The final guidance summarizes the agency’s position with...more

FDA Issues Long-Awaited Final Guidance on Interoperable Medical Devices

by Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) on Sept. 6, 2017, published the final version of its guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices. This final...more

Leveraged Lending: Summary of ECB Guidance compared to US Guidance

by Shearman & Sterling LLP on

In May 2017, the European Central Bank published its final Guidance on Leveraged Transactions (the “ECB Guidance”). The ECB Guidance will come into effect six months after publication and will apply to all “significant credit...more

ECB Guidance on Leveraged Transactions

by White & Case LLP on

The European Central Bank ('ECB') published its final guidance ('Final Guidance') on leveraged transactions on 16 May 2017, marking the end of a public consultation process that began on 23 November 2016. In addition to its...more

European Central Bank Publishes Final Guidance on Leveraged Transactions

by Latham & Watkins LLP on

The ECB final guidance reflects market feedback and is more closely aligned to the US leveraged lending guidance. The European Central Bank (ECB) published the long-awaited final guidance on leveraged lending on 16 May...more

Cybersecurity Disclosures: A How-To Guide

by Bryan Cave on

In October of 2011, the U.S. Securities and Exchange Commission (“SEC”) issued guidance regarding a public company’s obligations to disclose cybersecurity risks and cyber incidents (the “Cybersecurity Disclosure Guidance”)....more

UK Prudential Regulation Authority Publishes Final Consolidated Guidance on Remuneration

by Shearman & Sterling LLP on

The Prudential Regulation Authority has published a Policy Statement and final consolidated Supervisory Statement on its expectations on remuneration. In the latter part of 2016, the PRA consulted on its proposed changes to...more

CAS Legal Mailbag Question of the Week – March, 2017

by Shipman & Goodwin LLP on

Dear Legal Mailbag: I am sick and tired of parents who think that middle school education is unimportant. Every spring, I receive a spate of emails from parents notifying me that they will be taking their children out of...more

[Webinar] Biologics and Biosimilars: Development with an Eye Towards FDA Approval - February 17th, 10:00am PST/1:00pm EST

In January 2017, the U.S. Food and Drug Administration (FDA) released a highly anticipated draft guidance detailing the agency’s expectations for demonstrating biosimilar interchangeability with a reference product and final...more

FDA Response to Biosimilar Naming Petitionx Just Issued

by Goodwin on

On January 13, 2017, the FDA published a final version of its industry naming guidance Nonproprietary Naming of Biological Products. In it, the FDA specified a naming convention that gives biosimilar products and their...more

New Approach for Biologic and Biosimilar Names

by Morgan Lewis on

FDA final guidance will have significant impact on marketing of biologics, biosimilars and related products. This month, FDA issued its final guidance on Nonproprietary Naming of Biological Products (Naming Guidance)....more

Summary of FDA Guidance on the Nonproprietary Naming of Biological Products

On January 12, 2017, the U.S. Food and Drug Administration (“FDA”) released a final Guidance for Industry, Nonproprietary Naming of Biological Products, as part of the Agency’s ongoing efforts to implement the Biologics Price...more

What You Need To Know About the FDA’s Guidance on Postmarket Cybersecurity

by Reed Smith on

The FDA released its final Guidance on Postmarket Management of Cybersecurity in Medical Devices during the week between Christmas and New Year. You can link to a full copy here, and we gave you our detailed take on the draft...more

FDA Finalizes Guidance on Postmarket Management of Medical Device Cybersecurity

by Ropes & Gray LLP on

On December 28, 2016, the Food and Drug Administration (FDA) issued final guidance on the postmarket management of cybersecurity in medical devices. The guidance outlines nonbinding recommendations on how device manufacturers...more

News from Abroad: Summary Report on the Final Guidance from the English Court of Appeal on Second Medical Use Patents

The final decision of the Court of Appeal in the Lyrica® litigation was handed down on 13 October 2016. This litigation, relating to the painkiller pregabalin marketed by Warner-Lambert for the treatment of pain under the...more

FDA Issues Final Guidance Requiring Meaningless Suffixes for Biosimilar Names

Despite nearly universal opposition from both biosimilar makers and innovator companies, FDA has issued final guidance adopting its controversial August 2015 proposal for naming biologics. Under the guidance adopted by FDA,...more

FDA Issues Final Guidance on Postmarket Cybersecurity

by Morgan Lewis on

Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices. On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more

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