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).

After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the internationally accepted standard for medical device quality management systems established by the International Organization for Standardization, the 2016 edition of ISO 13485, “Medical devices - Quality management systems - Requirements for regulatory purposes” (known as “ISO 13485:2016”). We previously mentioned back in January 2021 that FDA had plans to initiate notice-and-comment rulemaking to describe the harmonization process sometime in 2021, plans that the agency had been discussing for years prior. FDA finally published a Notice of Proposed Rulemaking for the harmonization in February 2022 and, then, following the agency’s consideration of stakeholders’ submitted comments, it issued the Final Rule on February 2, 2024.

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 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.

A new battle is emerging in the fight for health equity, and it’s centered on the humble pulse oximeter. On November 1, 2023, 25 state attorneys general sent a letter to the Food and Drug Administration (FDA) demanding that the agency take urgent action to address pulse oximeter inaccuracies that continue to create health care risks for people of color. The letter comes exactly one year after a public meeting held by the Anesthesiology and Respiratory Therapy Devices Panel of the FDA’s Medical Devices Advisory Committee titled “Pulse Oximeter Accuracy and Limitations,” and nearly 21 months after the agency issued a safety communication about pulse oximeter inaccuracies when used on people with dark skin pigmentation (see our previous blog post on pulse oximeter performance here).

The capabilities and sophistication of digital health technologies are constantly expanding, especially with the integration of artificial intelligence and machine learning. Many companies, both existing and start-up, are developing software aimed at health care systems, hospitals, physicians, and lay-users for various levels of use, from assisting diagnoses in a clinical environment to tracking exercise and general health indicators in the home. In particular, a growing number of companies is focusing on the development of digital therapeutics - a class of software devices that deliver and monitor medical interventions for the purpose of treating, managing, or preventing certain diseases or conditions - for use in a patient’s home. With all of the new players jumping into the digital health technology game, we thought it might be useful to provide a brief primer on certain factors to consider when evaluating the potential regulatory requirements for such products.

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.

On August 7, 2023, the Food and Drug Administration (FDA) published Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (the Draft Guidance), which provides much-needed clarifications to the registration and listing requirements that will soon apply to cosmetics companies under the Modernization of Cosmetics Regulation Act (MoCRA), for review and public comment. MoCRA was signed into law in December 2022 (see our prior post here) and added significant new provisions on cosmetic products to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under Section 607 of the amended FD&C Act, facilities that manufacture or process a cosmetic product for distribution in the United States must register with FDA and submit a cosmetic product listing, and the Draft Guidance answers basic and essential questions about who must register and list, what information must be included, and how to submit information to FDA. This post summarizes key takeaways from the Draft Guidance and discusses its implications as the December 29, 2023 initial registration and listing deadline approaches.

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.

The Center for Devices and Radiological Health (CDRH), the section of the Food and Drug Administration (FDA) responsible for the regulation of medical devices, has issued a request for public comments on expanding patient access to medical technologies intended for use by patients in their homes.