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The United States Food and Drug Administration Medical Devices

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -

Artificial Intelligence and Learned Intermediaries

by Reed Smith on

In the July 7, 2017, “Artificial Intelligence” issue of Science, we were intrigued by a short piece in the “Insights” section on “Artificial Intelligence in Research” that discussed the future use of autonomous robots in...more

House Passes FDA Reauthorization Act; Would Reauthorize Key User Fee Programs and Lengthen Medical Device Malfunction Reporting...

by Saul Ewing LLP on

Last week, the U.S. House of Representatives (the House) passed by voice vote the FDA Reauthorization Act of 2017 (FDARA or the Act). Introduced on May 16, 2017 by House Energy and Commerce Committee Chairman Greg Walden...more

AGG Food and Drug Newsletter - July 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

Don’t give medical device makers more time before disclosing product woes

Pro-business and anti-consumer lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed...more

FDA House Legislation Would Relax Reporting of Medical Device Malfunctions

by Faegre Baker Daniels on

On July 12, 2017, the U.S. House of Representatives passed a bill to reauthorize four of the U.S. Food and Drug Administration’s user fees and to change various drug and device testing rules. H.R. 2430 – the FDA...more

Proposed Legislation to Relax Rules on Medical Device Reporting Passes U.S. House

by Cozen O'Connor on

On July 13, 2017, the U.S. House of Representatives passed a bill that would triple the amount of time in which medical device manufacturers are required to report certain malfunctions of some products to the Food and Drug...more

AGs Weave Themselves Into Patchwork of Digital-Health Regs

by Pepper Hamilton LLP on

There are more than 165,000 mobile health applications available for download in Apple’s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more

FDA Adds Additional Premarket Notification 510(k) Submission Requirements for Certain Reusable Medical Devices

by Arnall Golden Gregory LLP on

The 21st Century Cures Act included a provision requiring the Food and Drug Administration (FDA) to publish a notice in the Federal Register identifying a list of reusable devices that will be required to include validated...more

Blog: Off-Label Use Gets Congressional Hearing

by Cooley LLP on

Today, the House Energy and Commerce Committee will hold a hearing tilted “Examining Medical Product Manufacturer Communications.” According to the Committee, the focus of the hearing will be how the Food and Drug...more

Activity Trackers Eye Inactivity Tracking

by Knobbe Martens on

Fitbit recently announced plans to build sleep apnea diagnostics into its wrist-worn activity tracking devices, stating that it expects do so within a year.  If successful, Fitbit may be able to address a market that is...more

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

by Hogan Lovells on

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

A Double Whammy for California Design Defect Claims

by Reed Smith on

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue. Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803...more

FDA Reorganizes ORA Staff, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

On May 15, 2017, the Food and Drug Administration's ("FDA" or "Agency") Office of Regulatory Affairs ("ORA") began implementing a "Program Alignment Initiative." The Initiative requires the ORA staff, who are charged with...more

Eleventh Circuit Gets It Wrong on Preemption

by Reed Smith on

We have a point of view. Our readers understand that we represent folks on the right side of the v., and our posts tend to read cases and legal trends with a pro-defense bent, although you can rest assured that we put a lot...more

Washington, D.C. Update – June 2017

by Baker Donelson on

Having returned from its Memorial Day recess, Congress now enters one of the longest continuous work periods of the year and – with the exception of the week of the Fourth of July – will likely be in session until the end of...more

Capitol Hill Healthcare Update

by BakerHostetler on

Senate Republican leaders are expected to make a series of changes to the healthcare legislation released Thursday as they scramble to gain the support of at least 50 lawmakers in a showdown vote scheduled for later this...more

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

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