News & Analysis as of

510(k) RTA

Arnall Golden Gregory LLP

FDA Launches Pilot to Expand the Special 510(k) Program

by Arnall Golden Gregory LLP on

On October 1, 2018, the Food and Drug Administration (FDA) announced a pilot expansion of the Special 510(k) Program. The Special 510(k) Program was developed to help streamline the 510(k) premarket notification process for...more

Knobbe Martens

FDA Launches 'Quik' 510(k) Review Pilot Program

by Knobbe Martens on

The Food and Drug Administration (FDA) recently unveiled the Quality in 510(k) (“Quik”) Review pilot program, aimed at reducing the time it takes to review moderate-risk medical devices by one-third. The pilot, dubbed as “a...more

Hogan Lovells

New draft guidance proposes a shift in how the FDA will evaluate certain device modifications

by Hogan Lovells on

On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will supersede the currently in effect Special...more

Stinson Leonard Street

FDA Draft Guidance and Pilot Program Seek to Expand Device Modifications Appropriate for the Special 510(k) Program

by Stinson Leonard Street on

In its continued effort to reduce time to market for regulated products and improve transparency, the Food and Drug Administration (FDA) published a draft guidance last Friday that, among other things, proposes to (i) expand...more

Knobbe Martens

FDA to Strengthen Cybersecurity Oversight

by Knobbe Martens on

In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the...more

Mintz - Health Care Viewpoints

FDA Introducing a Variety of Programs to Help Medical Devices Get to Market

Over the past couple of years, FDA has introduced multiple programs allowing faster review of medical devices in order to get them to market more quickly. Some of the FDA’s efforts have been highly visible, such as the...more

Hogan Lovells

Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program

by Hogan Lovells on

Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market, companies in the digital health space are confronted with numerous challenges. ...more

Knobbe Martens

BioSig Technologies Receives FDA 510(k) Clearance for Its Noninvasive Electrophysiology Information System

by Knobbe Martens on

The Los Angeles-based medical device company BioSig Technologies, Inc. announced in a press release the FDA 510(k) clearance of its PURE EP System, which is designed to aid electrophysiology procedures, such as cardiac...more

Proskauer - Advertising Law

Court Puts “FDA-Cleared” Complaint on Ice

The Central District of California recently dismissed, for the second time, a putative class action filed by two plaintiffs who claimed to have purchased Zeltiq Aesthetics, Inc.’s “CoolSculpting” fat-reduction treatments...more

Knobbe Martens

First Thrombectomy Device Cleared for Pulmonary Embolisms

by Knobbe Martens on

The FDA announced 510(k) clearance for Inari Medical’s FlowTriever device for the treatment of pulmonary embolism (“PE”). According to Inari, the FlowTriever system is the first thrombectomy device cleared for the treatment...more

Cozen O'Connor

FDA releases draft guidance on expansion of abbreviated 510(k) Program

by Cozen O'Connor on

On April 12, the FDA released draft guidance discussing an expansion of its Abbreviated 510(k) program for medical devices. This new guidance would allow a submitter to establish substantial equivalence by demonstrating that...more

Knobbe Martens

Materialise Receives First-Ever 510(k) Clearance for Anatomical Model 3D Printing Software

by Knobbe Martens on

3D printing specialist Materialise recently received FDA 510(k) clearance for its Mimics inPrint software. Mimics inPrint is said to use to create 3D anatomical models from medical image data and output those models to a 3D...more

Hogan Lovells

Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) Pathway for certain devices

by Hogan Lovells on

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the historically underutilized...more

Arnall Golden Gregory LLP

(Don’t) Take the Long Way Home: FDA Issues Draft Guidance on Expansion of the Abbreviated 510(k) Program

by Arnall Golden Gregory LLP on

The Food and Drug Administration channeled, in the other direction, the 1979 Supertramp song, “Take the Long Way Home,” after it issued a draft guidance entitled, “Expansion of the Abbreviated 510(k) Program: Demonstrating...more

Arnall Golden Gregory LLP

AGG Food and Drug Newsletter - March 2018

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

Arnall Golden Gregory LLP

Checklists and Guidance from FDA on the Acceptance Criteria for 510(k) Submissions

by Arnall Golden Gregory LLP on

FDA recently issued a final guidance on the Refuse to Accept Policy for 510(k)s (Guidance). The Guidance outlines the procedures and criteria FDA uses to determine whether a medical device premarket notification (510(k))...more

Knobbe Martens

Akili Interactive Announces Trial Results for Video Game Treatment of ADHD

by Knobbe Martens on

Akili Interactive recently announced results of a trial on the company’s digital medicine product, AKL-T01. According to FierceBiotech, Akili plans to file AKL-T01 with the U.S. Food and Drug Administration (FDA) for...more

Knobbe Martens

FDA Announces Plans for Alternative Clearance Pathway

by Knobbe Martens on

The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in...more

Mintz - Health Care Viewpoints

FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality

This is the third installment of our year-in-review series covering major developments at FDA.  While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more

Arnall Golden Gregory LLP

AGG Food and Drug Newsletter - November 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

Arnall Golden Gregory LLP

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

Wilson Sonsini Goodrich & Rosati

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

K&L Gates LLP

Recent FDA Steps to Advance Medical Device Access and Innovation

by K&L Gates LLP on

On November 6, 2017, U.S. Food and Drug Administration (“FDA” or “the Agency”) Commissioner Dr. Scott Gottlieb reiterated the Agency’s commitment to advancing medical device access and innovation by stating, “[o]ur goal is to...more

Saul Ewing Arnstein & Lehr LLP

Medical Device Update: FDA Releases Device Change Final Guidances and Breakthrough Devices Draft Guidance, Qualifies First Device...

Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) took a number of steps to “advance medical device innovation and help patients gain faster access to beneficial technologies,” as characterized by FDA...more

Knobbe Martens

Medtronic Receives Regulatory Approval for Surgical Navigation Device

by Knobbe Martens on

According to Medtronic news release, the company recently received 510(k) clearance from the U.S. FDA and a CE mark from the E.U. for its StealthStation™ ENT surgical navigation system. The system will assist surgeons...more

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