News & Analysis as of

510(k) RTA

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

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

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

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

Medical Device Update: FDA Releases Device Change Final Guidances and Breakthrough Devices Draft Guidance, Qualifies First Device...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

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

Recent Warning Letters from FDA about Medical Devices: Investigational Device Exemptions and Lack of Marketing Authorization are...

by Arnall Golden Gregory LLP on

Over the past several months, the Food and Drug Administration (FDA) has issued several Warning Letters related to Investigational Device Exemption (IDE) requirements and misbranding. An IDE allows an investigational device...more

Does the NAD’s Capillus Decision Baldly Contradict the FDA?

by Kelley Drye & Warren LLP on

On September 12, the NAD released its decision in its review of the Capillus82 hair growth device (Case #6107). This case is unusual in that it addressed a challenge to a prescription-only medical device, and related closely...more

Excelsius GPSTM: Globus Medical Receives 510(k) Clearance for Robotic Surgery Platform

by Knobbe Martens on

Globus Medical announced early yesterday that the Excelsius GPSTM surgical platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as reported by a press release dated August 17, 2017....more

FDA Exempts Numerous Medical Devices from 510(k) Premarket Notification Requirements

by Knobbe Martens on

The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone...more

Embrace™ Neonatal MRI Device Gains FDA Clearance

by Knobbe Martens on

On July 20, 2017, the Food and Drug Administration announced the clearance of “the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)” to...more

Capitol Hill Healthcare Update

by BakerHostetler on

Congressional Republicans and President Donald Trump face a series of key questions about how or whether to fortify the Affordable Care Act – particularly in the law’s beleaguered individual exchanges – after the Senate last...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

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

I’m Not Dead (Yet): FDA Continues to Enforce Unlawful Product Promotion

by Arnall Golden Gregory LLP on

Many of us remember the classic bit in the epic 1975 Monty Python and the Holy Grail movie, where the Dead Collector asks the pestilence-infested community to bring out its dead, and one hapless individual calls out, “I’m not...more

Certain Medical Devices Exempted from 510(k) Requirements

by Knobbe Martens on

The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements. This publication was made by the FDA...more

FDA Approval for Medtronic’s Reveal LINQ ICM with TruRhythm Detection

by Knobbe Martens on

On March 13, 2017, Medtronic announced FDA 510(k) clearance for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection. Previously, Medtronic received Ministry of Health, Labor and Welfare approval for the...more

FDA to Exempt Over 1,000 Types of Medical Devices from Premarket Notification Requirements

On March 13, 2017, the U.S. Food and Drug Administration (FDA or the Agency) identified a list of 1,003 types of Class II medical devices that, when finalized, will be exempt from the Agency’s premarket notification (i.e.,...more

Voxello Receives FDA 510(k) Clearance for the Noddle Communication Device

by Knobbe Martens on

Voxello recently announced FDA 510(k) clearance of its noddle™ device, following submission of its application in October 2016. According to the press release, the noddle gives patients who are unable to speak a way to...more

FDA 2016 Year in Review

by McDermott Will & Emery on

The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

Where Equivalence Isn’t Equivalent: Using 510(k)s in Patent Litigation

Originally published in Medical Device and Diagnostic Industry - January 3rd, 2017. Medical devices—encompassing everything from contact lenses to hemodialysis machines—are fundamental components of modern medicine. The...more

FDA Issues Draft Guidance on 510(k) Third Party Review Program

by Arnall Golden Gregory LLP on

The Center for Devices and Radiological Health (CDRH) recently issued a draft guidance on the 510(k) Third Party (TP) Review Program. The TP Review Program (formerly known as the Accredited Persons Program) allows FDA to...more

Medical Device Updates: U.S. Food and Drug Administration (FDA) Releases Numerous and Important Draft Guidance Documents

by Mintz Levin on

The summer of 2016 saw a flood of new medical device-related guidance documents coming out of FDA’s Center for Devices and Radiological Health (CDRH). Some of these draft guidance documents, such as those addressing device...more

AGG Food and Drug Newsletter - October 2016

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

What a Difference a Claim Can Make: FDA Issues a Warning Letter for Unlawful Medical Device Promotion

by Arnall Golden Gregory LLP on

Much has been written, including by us, about the Food and Drug Administration’s enforcement approach (or lack thereof) concerning off-label promotion. However, FDA has not curled itself up into a ball, abdicating its...more

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