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Five Observations from FDA’s Responses to Comments in the Final Rule on LDTs
July 10, 2024 | Blog | By Benjamin Zegarelli
Now that the final rule on laboratory developed tests (LDTs) has been available for over a month and the stages of the enforcement discretion phaseout process and the Food and Drug Administration’s (FDA’s) newly proposed policies for continuing limited enforcement discretion for certain types of LDTs have been thoroughly described and dissected (including by us in our previous post), it’s high time to dig into FDA’s perspectives on the comments it received on the proposed rule.
FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to Stakeholders
May 6, 2024 | Blog | By Joanne Hawana , Benjamin Zegarelli
The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency’s arduous decade-plus-long journey toward winding down its historical enforcement discretion posture for LDTs. But FDA’s crusade is far from over. It will have much to do to implement the four-year phase-out period described in the final rule and those efforts may be delayed by litigation seeking to enjoin implementation of the rule altogether. While we wait for the litigation shoe to drop, let’s take a look at what the final rule says and the changes FDA made in these highly significant policy decisions since the Notice of Proposed Rulemaking was published on October 3, 2023 (see our previous posts on the NPRM here and here).
FDA Warning Letter Is a Stark Reminder That If You Claim Your Product Is RUO, It Has to Be RUO
April 3, 2024 | Blog | By Joanne Hawana , Benjamin Zegarelli
In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates on behalf of the U.S. public. IVDs are classified as medical devices and include “reagents, instruments, and systems intended for use in diagnosis, including determining the state of health, through the collection, preparation, and examination of specimens taken from the human body.” Unlike human drug and non-IVD device products, which generally must be authorized for a specific medical use prior to commercialization, IVD products may be sold for certain scientific research studies without FDA authorization, but such IVD products may not be sold for clinical diagnostic use.
Health Law Diagnosed – A Discussion on the Regulatory Requirements for LDTs
March 7, 2024 | Podcast | By Bridgette Keller, Joanne Hawana , Benjamin Zegarelli
In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory developed tests (LDTs).
FDA Faces Critical Deadlines in 2024, Even Without an Election Looming
March 6, 2024 | Blog | By Joanne Hawana
The American public knows that 2024 is a critical election year, with the next race for the presidency in November expected to be another face-off between President Biden and former President Trump. What the majority may not know quite as well, however, is how many important regulatory programs the Food and Drug Administration (FDA) has tasked itself with completing sometime this year. Given the centrality of much of FDA’s work to the average American consumer and all users of health care services, not to mention the various business stakeholders whose operations can be shaped in part by policy decisions executed by the agency, this blog post will preview upcoming milestones that FDA is expected to meet in 2024.
2023: Another Year Chock Full of Challenges for FDA
December 20, 2023 | Blog | By Joanne Hawana , Benjamin Zegarelli
In 2023, the FDA navigated challenges while achieving significant public health milestones. Member Joanne Hawana and Of Counsel Benjamin Zegarelli highlight key takeaways from the year, addressing multifaceted issues such as CBD regulation, the overhaul of in vitro clinical tests, and the management of manufacturing failures. These pivotal topics underscore the FDA’s proactive approach to evolving healthcare regulations and technological advancements.
The LDT Debate: Unpacking Public Responses to FDA’s Proposed Rule
November 20, 2023 | Blog | By Benjamin Zegarelli, David Gilboa
The U.S. Food and Drug Administration (FDA) recently released a proposed rule that would seek to regulate laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This rule could reshape the landscape of LDTs and, as expected, has generated substantial attention and feedback from the public, with both supportive and negative comments flooding in. We previously provided a summary of the proposed rule and FDA’s lengthy justification for it here. In this blog post, we will examine some of the key arguments presented in the public comments submitted to Docket FDA-2023-N-2177, as well as public statements published by industry trade associations.
Five Topline Takeaways from FDA’s Proposed Rulemaking on Lab-Developed Tests
October 2, 2023 | Blog | By Joanne Hawana , Benjamin Zegarelli
It came as a surprise to nobody in health care circles when, on Friday, September 29, 2023, the Food and Drug Administration (FDA) publicly announced that its much-anticipated proposed rule on laboratory developed tests, or LDTs, had made it through internal regulatory review processes and would be published imminently in the Federal Register. The agency moved very quickly following the White House Office of Management and Budget’s clearance of the rule, which had occurred just two days prior, likely due to the high probability that the federal government was going to shut down on October 1 if Congress did not come to a budget agreement. That shutdown was narrowly averted over the weekend, but had it not been, the last significant publication of the Federal Register would have been on Tuesday, October 3.
FDA Opens a Pilot Program to Scrutinize Certain Laboratory Developed Tests, But Will It Generate Sufficient Interest?
June 28, 2023 | Blog | By Benjamin Zegarelli
The U.S. Food and Drug Administration (FDA) announced a new pilot program on June 21, 2023 that gives sponsors of oncology products the opportunity to submit validation and performance data for laboratory developed tests (LDTs) intended to support patient selection for such drugs. Although the pilot is limited to only nine participants, it is unclear based on the requirements of the program whether it will generate sufficient interest among oncology product sponsors to meet the objectives that the agency has established for it.
FDA Is Accepting EUA Requests for Monkeypox Tests, But Time is of the Essence
September 28, 2022 | Blog | By Benjamin Zegarelli, Joanne Hawana
The Food and Drug Administration (FDA) issued a guidance on development and emergency use authorization of diagnostic and serological tests for the monkeypox virus following the Secretary of the Department of Health and Human Service’s declaration of a public health emergency under Section 564 of the Food, Drug and Cosmetic Act on August 9, 2022. Subsequently, the Secretary declared on September 7 that in vitro diagnostics for monkeypox were needed to respond to the public health emergency, and the FDA released its guidance on the same day. The monkeypox test guidance describes the agency’s general expectations and approach for test development and validation, as well as the EUA request process.
FDA Comes Through on Promise to Release NGS Device Draft Guidelines Expeditiously
July 12, 2016 | Alert | By Joanne Hawana
Biosimilars and FDA Regulatory Webinar Recap
February 2, 2016 | Blog | By Joe Rutkowski
FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial
July 21, 2015 | Alert
FCC Modifies Cost Recovery Rules for Medical Device Tests and Proposes Greater Access to MedRadio Bands for Testing
July 13, 2015 | Advisory | By Russell Fox
Public Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA’s Hackles if They Do Not Meet Basic Requirements for Promotional Communications
June 23, 2015 | Advisory | By Joanne Hawana
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