News & Analysis as of

Premarket Approval Applications

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

Cures Act Developments: FDA Proposes Class II Device Exemptions

Since the 21st Century Cures Act became law on December 13, 2016, we have been blogging on regulatory and clinical areas affected by its provisions. On March 14, 2017, FDA made further progress on its Cures Act obligations by...more

POM Wonderful Returns – Lanham Act False Advertising Claim Against Home Pregnancy Tests Not Precluded by FDCA

by Dorsey & Whitney LLP on

On September 9, 2016, the Court of Appeals for the Second Circuit issued an interesting decision in a false advertising case involving a dispute between competitors in the home pregnancy testing market. Church & Dwight Co. v....more

FDA Issues New Draft Guidance: New Dietary Ingredient Notifications and Related Issues

Dietary supplements are big business. A recent estimate pegs the U.S. market for dietary supplements at over $35 billion annually. The U.S. Food and Drug Administration (FDA) estimates the number of dietary supplements to be...more

FDA Issues Draft Guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Medical Device"

On August 8, 2016, the U.S. Food and Drug Administration (FDA) issued draft guidance on the important topic of deciding when to submit a new 510(k) premarket notification application (510(k)) for a change to an existing...more

Even with a Road Map, Only One Dubious Claim Navigates Preemption

by Reed Smith on

Here’s another guest post, this time from Reed Smith‘s Jaimee Farrer.  This post concerns PMA preemption, and a second opinion largely getting rid of a case that we blogged about before.  As always, Jaimee deserves all the...more

Dual Tracks Taken by FDA in Approving Products by ‘Big Pharma’

Prescription drugs exist to boost the health of patients by decreasing their pain, increasing their stamina, staving off infections and treating their symptoms. The U.S. Food and Drug Administration has the responsibility to...more

Medical Device Updates: U.S. Food and Drug Administration (FDA) Practice Trends

by Mintz Levin on

Data and Analytics — FDA’s Post-market Surveillance Data Proposals Press Forward - FDA’s National Evaluation System for Health Technology, or NEST, as FDA calls it, is quickly gaining traction as one of the...more

Guest Post – Highlights of FDA Draft Guidance on 3D Printing

by Reed Smith on

Another guest post today, this one by Reed Smith’s Matt Jacobson on the draft guidance document released earlier this week by the FDA. With the 3D printing of medical devices at the forefront of the burgeoning additive...more

FDA Recommends Medical Device Manufacturers Implement a Comprehensive Cybersecurity Risk Management Program in Accordance with...

by Epstein Becker & Green on

Medical devices increasingly contain software or connect to networks that may leave the devices vulnerable to cyber-attacks. The U.S. Food and Drug Administration (“FDA”) has recognized the potential risks that these...more

FDA Classifies Transvaginal Pelvic Mesh As “High Risk” Medical Device

by Knobbe Martens on

The U.S. Food and Drug Administration issued two final orders on Monday, January 4, 2016 to strengthen the data requirements for transvaginal surgical mesh devices that repair pelvic organ prolapse (POP). First, the agency...more

Bills Introduced to Streamline FDA Review of Medical Devices

by Knobbe Martens on

U.S. Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) recently introduced the Rare Device Innovation Act and the FDA Regulatory Efficiency Act.  The bills, if passed, would streamline the U.S. Food and Drug Administration...more

Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?

by Foley & Lardner LLP on

Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more

Making Sense of the Daubert and Summary Judgment Orders in A Metal-on-Metal Hip Implant Bellwether Case

by Reed Smith on

We have not posted for a while—that day job can really get in the way sometimes—so we agreed to tackle the ridiculously long decision in Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist....more

In Case of Good Judge, Break Glass – Implied Impossibility Preemption in Cases Involving §510(k) Cleared Medical Devices

by Reed Smith on

We have alluded on a couple of occasions to the likelihood that the recent generic drug implied impossibility preemption decisions in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S....more

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

by Foley & Lardner LLP on

Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

FDA Announces Medical Device User Fee Rates for Fiscal Year 2016

by Reed Smith on

Earlier this week, the federal Food and Drug Administration (FDA) issued a notice in the Federal Register (80 Fed. Reg. 46033) announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY)...more

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

by Morgan Lewis on

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

VertiFlex Announces FDA Approval of Superion Interspinous Spacer System

by Knobbe Martens on

VertiFlex, Inc., announced that it has been granted pre-market approval by the FDA for its minimally invasive treatment of lumbar spinal stenosis, the Superion Interspinous Spacer System.  This approval comes after a...more

FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

by McDermott Will & Emery on

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

FDA Issues Additional Guidance Documents for Compounding Pharmacies and Outsourcing Facilities; Addresses Repackaging

The U.S. Food and Drug Administration (FDA) announced the availability of four new Draft Guidance documents and a draft Memorandum of Understanding (MOU) between the FDA and individual states. The Draft Guidance documents...more

Considering Sex-Specific Variation for Personalized Medicine

by Foley & Lardner LLP on

Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more

FDA Releases Long-Awaited LDT Regulatory Framework and Finalizes Companion Diagnostics Guidance

by Ropes & Gray LLP on

On July 31, 2014, the Food and Drug Administration (FDA) took several significant actions to clarify its policies regarding regulation of certain in vitro diagnostic devices (IVDs). First, FDA released its long-awaited plan...more

Medical Device Update: FDA Issues Final Guidance on 510(k) Determinations, Use of “Split” Predicates Strongly Discouraged

by Morgan Lewis on

On July 28, the Food and Drug Administration (FDA) issued a final guidance titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” Device manufacturers should be aware of key...more

FDA Issues Final Guidance on Evaluating Substantial Equivalence in 510(k) Submissions

by Ropes & Gray LLP on

On July 28, 2014, the Food and Drug Administration (“FDA”) issued final guidance regarding the agency’s substantive review of Traditional 510(k) premarket notifications. This document, titled “The 510(k) Program: Evaluating...more

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