FDA in Flux — April 2026 Newsletter

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

New Program for Home-Health Devices Aimed at Reducing Hospital Readmissions

What is happening: On April 7, 2026, FDA announced its Reducing Readmissions through Device Innovation for the Home (READI-Home) innovation challenge, hoping to identify devices that can be used after a patient returns home from an acute hospital stay and ultimately help prevent avoidable hospital readmissions. When evaluating manufacturers’ submissions, FDA will generally consider, among other things, whether:

• the device is intended to address an unmet or emerging home health care need;
• the intended users include the patient or caregiver (i.e., the device cannot be restricted to health care professional use or supervision);
• the intended user environments include a home or community environment (i.e., patients cannot be under constant health care professional supervision);
• there is sufficient evidence supporting use of the device to reduce or prevent hospital readmission for the target population; and
• there is sufficient evidence supporting device feasibility.

The submission phase ends on September 30, 2026, and FDA will select up to nine devices, each from a different manufacturer, by December 4, 2026 to participate in the “interaction phase.” During this phase, participants will engage in sprint discussions with FDA and be able to demonstrate their technologies at FDA’s research facilities.

Why it matters: The READI-Home innovation challenge advances a key agency goal to facilitate greater access to at-home device technologies, which both FDA Commissioner Dr. Marty Makary and Center for Devices and Radiological Health (CDRH) Director Dr. Michelle Tarver have highlighted over recent months. The program was created under CDRH’s broader Home as a Health Care Hub initiative, which was launched in early 2024 and which seeks to reimagine the provision of health care in the US. Although many companies develop medical devices intended for home use, such as wearables to track health data or diagnostic tests, FDA’s focus on such products while emphasizing specific objectives like reducing hospital readmissions can help direct innovation toward addressing unmet needs and reducing health care costs.

Who may be affected: Device manufacturers participating in the READI-Home program will experience the most immediate advantages by accessing valuable interactions with FDA to facilitate the development and validation process. Patients and caregivers also stand to benefit greatly from an expanded attention to devices designed to assist care in a home environment and prevent hospital readmissions. Furthermore, the READI-Home challenge may indicate that FDA is willing to offer additional opportunities to incentivize medical device innovation, extending potential benefits to many more manufacturers. The agency’s goal to advance at-home devices also enhances the value of companies developing such technologies and may spur increased investments in both private and public markets.

HHS Requests that Congress Expand FDA’s Statutory Authorities Across Most Program Areas

What is happening: The Department of Health and Human Services (HHS) recently submitted its FY2027 budget request to Congress, which keeps funding for FDA relatively steady compared to the FY2026 budget enacted in mid-November 2025. A document accompanying the budget request contains a lengthy list of FDA legislative proposals for amending the Federal Food, Drug, and Cosmetic Act (FD&C Act) or other statutes that authorize the agency’s various programs and activities. HHS and FDA’s legislative requests cover diverse topics, such as:

• Adding explicit language to the FD&C Act that an advertisement for a compounded drug renders the drug misbranded if it (1) fails to disclose the drug is not approved or evaluated by FDA for safety, effectiveness, or quality; (2) represents that the drug is safe and effective without evidence or mispresents available data; (3) makes “misleading comparative claims to a particular FDA-approved drug or class of drugs”; or (4) omits risk information about the drug. The current statute provides only that “if the advertising or promotion of a compounded drug is false or misleading in any particular,” it will be deemed misbranded.
• Creation of another licensure pathway for biological products that would allow abbreviated applications for “products that are intended to differ from an FDA-approved biological product” (which are not biosimilars and thus cannot use the available biosimilar application process). Such a pathway is envisioned as being analogous to a follow-on new drug application submitted under Section 505(b)(2) of the FD&C Act. The agency notes for Congress that an abbreviated application pathway accommodating biological product improvements or modifications could increase innovation and competition in these still-emerging markets.
• Providing an “alternative to the burdensome” investigational new drug application (IND) pathway for certain Phase 1 clinical trials, with the goal of “reduc[ing] duplicative and time-consuming requirements while maintaining safety and ethical standards.” FDA suggests that an alternative application for initiating first-in-human studies of an investigational product will “encourage US biotechnology investment” and support the Trump administration’s efforts to “onshore the pharmaceutical industry.” The details of FDA’s proposed “Expedited IND” are not described in the FY2027 budget document, so the availability of and administrative processes associated with such an option remain unclear. Such a development would represent a major shift in US regulatory processes for early-stage clinical trials; stakeholders should follow the evolution of this proposal and take advantage of opportunities to provide feedback.
• Explicitly granting FDA authority to release Complete Response Letters (CRLs) for unapproved products — which the agency began doing in September 2025, as discussed in a previous newsletter, and which are now in a centralized CRL database — and permanently authorizing the Rare Pediatric Disease Priority Review Voucher (PRV) program. FDA notes that permanent PRV authorization would provide “more predictability for sponsors.”
• Amending the Mutual Recognition Agreement authority in the FD&C Act to allow FDA to recognize foreign regulatory agencies’ inspection reports related to good laboratory practice (GLP) or good clinical practice (GCP) audits, providing more flexibility, and therefore efficiency, into agency decision-making. 

Additional legislative proposals address areas such as medical device importation, enforcement authorities for tobacco products, reforming certain generic drug application procedures to increase competition and benefit American manufacturers over foreign companies, and enhancements to FDA’s ability to conduct effective “post-market surveillance of food chemical safety.” 

Why it matters: A request for new authorities or for changes to the statutes governing the agency’s programs and activities does not necessarily mean that Congress will take immediate or any action to implement what HHS/FDA have asked for. The annual legislative requests document does, however, provide key insights into the executive branch’s overall directional priorities for FDA and the industries it regulates. Individual proposals may be taken up by congressional champions or other stakeholders that may focus lobbying efforts on them, leading to the potential for future enactment. FDA-specific reforms can often be tacked onto various legislative vehicles, most notably (but not solely) the prescription drug, medical device, biosimilar, and generic drug user fee reauthorization bills that will need to be passed by Congress in 2027 to ensure the continuation of those programs. Accordingly, each of the proposals in the FDA budget document has the potential to move forward into an implementation stage. Interested stakeholders should get their viewpoints on such changes into the public record to ensure all relevant information is considered during the legislative process. 

Petition for Deregulation of Certain AI-Enabled Devices Rejected by FDA

What is happening: FDA recently issued a final response rejecting a citizen petition that asked the agency to exempt certain AI-enabled, computer-assisted detection/diagnostic/triage (generally, “CAD”) devices from 510(k) premarket notification requirements. 

Essentially, the petition argued that CAD device manufacturers who already obtained 510(k) clearances for similar devices should be exempt from submitting notifications for devices of the same type because the prior clearances “reflect[] proficiency in processes that apply not only to the device under review, but to all devices developed under those processes.” The petitioner argued that further assurances of device safety and effectiveness could be provided by establishing a “a robust post-market plan, transparency, and training measures.” 

FDA’s response thoroughly explains why the petitioner’s proposal is not consistent with the statutory process for device authorization and does not adequately assure that potential risks and quality issues will be properly addressed. In addition, FDA describes in detail why the petitioner failed to meet the agency’s four criteria for exempting devices from 510(k) requirements (see FDA’s final response letter for further details).

Why it matters: FDA’s rejection of the petition shows that the agency is wary of applying broad exemptions to device regulations, especially when the proposed alternative could substantially reduce standards of device safety and effectiveness. This despite the Trump administration’s overarching preference for lowering regulatory barriers and FDA’s recent guidance revisions that appeared to relax requirements on clinical decision support software and certain digital health / wellness products (as discussed in the January edition of FDA in Flux). The petitioner attempted to appeal to those deregulatory and AI-boosting inclinations by claiming that the proposed exemptions would promote AI innovation and align with President Trump’s AI Action Plan. 

FDA’s strong rebuttal, grounded in long-established agency policies, provides evidence that it remains focused on regulatory oversight to assure product safety and effectiveness and that it will carefully evaluate regulatory and policy proposals to determine whether they are in the best interests of the public health. 

Who may be affected: By rejecting the citizen petition, FDA’s standards for reviewing CAD devices remain unchanged. Had the agency permitted the proposed exemptions to take effect, it may have led to similar exemptions for other AI-enabled software devices (and perhaps many other devices) because the petitioner’s logic could potentially be applied to all class II devices. Instead, FDA highlighted the utility of the 510(k) process to assure the safety and effectiveness of new-to-market devices and the value of predetermined change control plans (PCCPs) to lower certain regulatory burdens for AI-enabled devices. In doing so, the agency reaffirmed its role in the device process as well as its capacity to adopt new methods that do not undermine FDA’s consumer protection mission. 

FDA Sets Aside Historical Enforcement Posture on CBD-Containing Dietary Supplements to Support New Medicare Program

What is happening: Responding to an executive order from President Trump to improve patient access to hemp-derived cannabis products, the Centers for Medicare and Medicaid Services (CMS) launched a new pilot program on April 1, 2026, under which physicians may discuss and recommend “eligible hemp products” to Medicare beneficiaries. Eligible products must be orally ingested and contain no more than 0.3% delta-9 tetrahydrocannabinol (THC) and no more than 3 milligrams per serving of THC. 

Although the legality of the CMS pilot program has been challenged under the Administrative Procedure Act, both CMS and FDA are taking steps to implement it while the litigation is ongoing. Notably, in a letter dated April 1, Commissioner Makary notified the leaders of the agency’s human food and human drug centers that FDA would not consider “an orally administered, hemp-derived cannabidiol [CBD] product” an unapproved new drug “solely on the basis that it contains CBD,” so long as the product is:

1. Labeled, marketed, and manufactured as a dietary supplement (i.e., does not make disease claims);
2. Not contaminated;
3. Not marketed to children or packaged in a way that would be attractive to children; and
4. Provided to a Medicare beneficiary under the direction of a treating physician. 

Why it matters: The criteria listed in the commissioner’s letter contradict a long-standing agency interpretation of the FD&C Act, under which FDA “concluded that THC and CBD products are excluded from the dietary supplement definition” in the Act and therefore cannot be sold legally in interstate commerce. Since Congress removed “hemp” from the Controlled Substances Act in 2018, FDA has issued many warning letters to marketers of CBD-containing food products, including dietary supplements, and has also clearly articulated the safety concerns associated with such products (for example, see here and here). FDA’s shift toward more relaxed enforcement of this class of products when used by Medicare beneficiaries creates legal tension and enforcement inconsistency, while increasing public health risks. 

Who may be affected: The direct impact of FDA’s new enforcement policy for CBD-containing dietary supplements is limited to products recommended and used in accordance with the CMS pilot program. However, the agency’s laissez-faire approach in this context represents a significant policy shift with respect to the safety, legality, and appropriate use of such products and may lead to confusion among manufacturers, distributors, retailers, health care providers, and consumers. Sellers of CBD-containing supplements should be cognizant of the narrow scope of this new CMS/FDA program and continue to be cautious in labeling and marketing their products. 

Interested stakeholders should also keep an eye on another related announcement from FDA that is currently pending at the White House Office of Management and Budget (OMB). According to the OMB regulatory review dashboard, an FDA document entitled “Cannabidiol (CBD) Products Compliance and Enforcement Policy” was submitted on March 13, and federal government officials have held several related meetings with stakeholders since that time. This upcoming compliance policy announcement from FDA may broaden the agency’s hands-off approach to CBD-containing foods and dietary supplements. Sellers of such products looking to maximize the benefit from any relaxation in FDA enforcement policies should carefully analyze the relevant criteria or carve-outs that may be announced by the agency.

OPDP Warning Letter Features Fundamental Promotional Violations, Reinforces that the Rules Apply to Everyone

What is happening: In a warning letter dated March 13, 2026, the Office of Prescription Drug Promotion (OPDP) strongly objected to advertising for a complex biological product approved for a specific form of bladder cancer. OPDP’s decision to escalate to a warning letter in this case is likely related to the recipient’s failure to correct misleading promotional messages for the drug, as the letter notes OPDP had alerted the company to “similar” issues via September 9, 2025 and January 7, 2026 untitled letters. Many of the problems cited in the March 13 letter arise from a company-generated podcast that originally aired in mid-January, highlighting the efficiency with which OPDP is acting under the current administration (discussed in our February 2026 newsletter). 

Why it matters: Amid the ongoing self-declared FDA/HHS “crackdown” on pharmaceutical advertising, companies disseminating any form of promotional content for prescription drugs should remain vigilant. Some may want to reassess their processes for determining when claims are consistent with the drug’s prescribing information and appropriately supported with the right type of data — which can be challenging due to the complexity associated with such issues. At the same time, foundational principles should not be overlooked or deprioritized. The March 13 OPDP warning letter reinforces certain of those principles and reminds industry that codified regulations must not be ignored. 

Among other things, the letter emphasizes that:

• A product approved for a specific indication (such as bladder cancer) cannot claim that it can treat other types of cancers — or even “all cancers” — without being false or misleading.
• Broad claims that the product can “prevent cancer” do not fall within the approved indication and also misbrand the product.
• Details of the approved indication are critically important — for example, here the product is approved for use “in combination with” another immunotherapy, which the company’s ads had not clearly disclosed.
• Referring to a drug’s route of administration as a subcutaneous injection (or implying such with the reference to a “single jab”) and showing imagery of a patient being injected in the arm with a syringe is misleading when that route had not been studied or approved.
• Fair balance between benefit and risk information cannot be an afterthought, and failing to include any risk information in a promotional piece is always noncompliant.
• When a TV ad “fades to black,” OPDP believes that “typically signals the close or end of a presentation” — so if important information is going to come afterward, consumers should be clearly informed so they can stay tuned in.
• Podcasts and other nontraditional advertising formats are not immune from OPDP review.

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