FDA Regulatory

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.

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the Digital Health Center of Excellence, implementing predetermined change control plans, and issuing various digital health guidances on device software functions, clinical decision support software, cybersecurity, and other topics. In anticipation of FDA’s Artificial Intelligence /Machine Learning (AI/ML) Medical Devices Workshop in October 2021, we posted a brief history of the agency’s regulatory oversight of software through the traditional medical device regulatory framework established in the 1970s, in which we highlighted the numerous challenges associated with such an approach. But now, with the rise of artificial intelligence and machine learning and the proliferation of AI/ML-enabled software throughout the health care industry, FDA is facing enormous challenges using an outdated, procrustean regulatory framework to maintain standards of safety and quality for such software devices. It is becoming increasingly clear that innovation in the AI/ML and digital health technology space is advancing rapidly, as FDA Commissioner Rob Califf has emphasized in many recent public appearances, and that the traditional device framework is quickly becoming unworkable for such technologies.

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).

Since the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law, cosmetics companies have spent the past year preparing to comply with its provisions. This includes the facility registration and cosmetic product listing requirements that have were mandated by Congress in the new law. Under MoCRA, the statutory deadline for meeting these foundational requirements is set at December 29, 2023 (one year after MoCRA’s enactment). However, on November 8, 2023, the Food and Drug Administration (FDA) issued Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (Compliance Guidance) and announced that enforcement of facility registration and cosmetic product listing requirements will be delayed six months.

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.

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.