This Week at FDA: FDA proposes FY27 budget, rejects software petition; and former CDRH leaders launch venture capital fund

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, the FDA presented its proposed budget to Congress, the agency rejected a petition for a partial 510(k) exemption for certain software products, and former top CDRH officials launched a venture capital firm.

The big news this week is that FDA submitted its budget proposal to Congress, outlining its spending priorities for fiscal year 2027. The agency's budget request totals $7.2B, including $3.3B in appropriations and $3.9B in user fees. If approved as is, it would mean an increase of approximately $232M, or 3.3%, compared to fiscal year 2026.

After significant public input and consideration, FDA issued a final response letter (FRL) rejecting a petition for partial exemption from 510(k) requirements for radiology Computer-Aided Detection and/or Diagnosis (CAD) and Computer-Aided Triage and Notification (CADt) devices, including radiological computer-assisted diagnostic software for lesions suspicious of cancer (CADx), medical image analyzers (CADe), radiological computer aided triage and notification software (CADt), and radiological computer-assisted detection and diagnosis software (CADe/x). The agency laid out its argument for why it would not be in the public interest to allow such exemptions and why it legally cannot do so.

Medtech Strategist reported this week that several top former FDA officials from the Center for Devices and Radiological Health (CDRH) have launched a new venture capital fund called White Oak 66 Capital. The co-founders include former CDRH Director Jeff Shuren, CDRH Chief Scientist and Deputy Director Douglas Kelly, and Ross (Rusty) Segan, director of the Office of Product Evaluation and Quality (OPEQ).

The Washington Post reported that Jay Bhattacharya, director of the National Institutes of Health (NIH) and acting director of the Centers for Disease Control and Prevention (CDC), has delayed publishing a CDC report that found COVID-19 vaccines cut the likelihood of emergency department visits and hospitalizations for healthy adults last winter by about half due. The delay is due to concerns about the study's methodology, according to the Post’s reporting. The decision has raised concerns among current and former public health officials that it is an ongoing effort by Health and Health Secretary Robert Kennedy Jr., a vaccine skeptic, to downplay the safety and efficacy of the vaccines.

Drugs & Biologics

The Center for Biologics Evaluation and Research (CBER) published three updated standard operating policy and procedures (SOPP) used by agency staff when reviewing products, including one on expediting the review of breakthrough therapies. The agency noted that the updates to the SOPP remove redundant steps regarding holds and weekly reports.

CBER updated an SOPP on reviewing and expediting fast-track designated drugs, which it said also removed redundant steps regarding holds. The third updated SOPP is regarding the review and evaluation of proposed proprietary names for biological products. The agency said it made minor word changes and corrected typos. A CBER spokesperson told Focus, “Remember, when you make a typo, the errorists win!”

FDA approved the first generics of AstraZeneca's Farxiga (dapagliflozin), intended to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and either established cardiovascular disease or multiple cardiovascular risk factors, and to be used alongside diet and exercise to improve glycemic control in people with type 2 diabetes. The agency also updated its Orange Book, which lists 81 entries for dapagliflozin or dapagliflozin in combination with another drug.

FDA announced it is hosting a hybrid two-day workshop starting on 7 May on optimizing pregnancy registries to allow stakeholders to discuss challenges in designing and implementing pregnancy registries. The agency said it will also allow them to discuss different approaches to improve the design and conduct of pregnancy registries that can be used to inform the safety of drugs and biologics during pregnancy.

FDA published a slew of consumer alerts for products including WAP, Curcuflex, RM Joe, DINA Acido Hialurónico, KUKA FLEX CBD, and Yeicob Ácido Hialurónico marketed as treatments for joint pain and sexual enhancement. The agency said the products are often sold online and contain unlisted ingredients that may cause side effects such as low blood pressure and reduce the body's ability to fight infections.

FDA is hosting a two-day workshop starting on 5 May to discuss the advancements and challenges in the field of generic oral drug products that has led to new bioequivalence (BE) approaches when conventional in vivo bioequivalence study designs are not feasible. The agency said attendees will learn about the intricacies of developing generic oral products across diverse areas and reformulated drug products intended to mitigate nitrosamine risks.

Blaine Labs initiated a voluntary recall for three lots of its Wound Care Gel products, 1 oz. and 3 oz. (0.1% benzalkonium chloride), due to concerns about microbial contamination after finding Lysinibacillus fusiformis during testing. FDA noted that patients with open wounds, compromised skin barriers, or weakened immune systems who use the products may be at increased risk of infection, skin irritation, and delayed wound healing, which may ultimately become life-threatening.

Medtech

CDRH announced the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge, intended to encourage the development of medical devices that help reduce hospital readmissions. The challenge echoes many of the benefits CDRH has promoted with its Home as a Health Care Hub and notes that participants would benefit from early engagement with regulators.

Baxter has sent out “Urgent Medical Device Correction" letters to customers using its Volara system single-patient use circuits, a non-continuous ventilator used to intermittently deliver an aerosol to a patient’s lungs or to assist breathing. FDA noted that the correction is part of a class I recall in which users did not receive the instructions for use addendum that notifies them of the risk of decreased oxygen levels or potential lung tissue injury from overexpansion when the devices are used in the home care setting. 

Medline Industries issued a class I recall pulling its Namic Angiographic Rotating Adaptor (RA) Control Syringes and Convenience Kits containing RA Syringes from the market after reports that the syringe rotating adaptor on affected devices may unwind during use, leading to a loose connection or full disconnection between the syringe and manifold. FDA noted that loose connections and disconnections may ultimately lead to serious injuries or death.

In a related matter, FDA also issued an early alert for certain AVID Medical angiographic syringes included in convenience kits that are part of Medline’s Namic Angiographic Control Syringes with Rotating Adaptor recall. The company has asked users to stop using the products for the same reasons that Medline issued its recall.

FDA issued an early alert for certain Cook Medical sizing catheters. The agency said the company has issued letters to potentially affected customers due to concerns that the marker bands on some products may be more prone to cracking and breakage.