This Week at FDA: Makary’s initiatives stay at FDA, CDRH celebrates 50 years of medtech regulations, and more

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 HHS said several of former FDA Commissioner Marty Makary’s initiatives would continue to be implemented at the agency, the device center celebrated 50 years of the law that created the modern medtech regulatory framework, and more.

Fierce Biotech reported that despite Makary's departure from FDA, several of his policy initiatives, including the controversial Commissioner’s National Priority Voucher (CNPV) program, will continue. A Department of Health and Human Services (HHS) spokesperson confirmed that there would be no change in the program's name or direction, and that other reforms will continue to move forward.

Michelle Tarver, director of the Center for Devices and Radiological Health (CDRH), published a blog post this week celebrating the 120th anniversary of FDA and the 50th anniversary of the enactment of the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). She highlighted the importance of the amendment in creating the modern medical device and diagnostics regulatory framework, while emphasizing the need to look forward as medical technologies continue to evolve.

FDA issued several guidances this week, including a draft guidance on reducing the need for animal testing in nonclinical safety assessments for certain cancer drugs. The guidance is part of the agency's broader efforts to reduce animal testing requirements in medical product development.

FDA extended its notice seeking feedback from stakeholders on a proposed pilot program on how artificial intelligence (AI)-enabled technologies can be used to improve efficiency, speed, and quality of decision-making in early-phase clinical trials. The agency said it has received stakeholder requests for an extension and has decided to extend the comment period from 29 April to 29 June.

FDA published the latest Medical Device User Fee Amendments (MDUFA V) performance report on 19 May. It found that first-cycle major deficiency rates for PMA originals have started to tick up again, but the average turnaround time to MDUFA decisions for PMA originals has significantly decreased, largely due to shorter average time the application spends with the manufacturer.

Drugs & Biologics

The Drug Safety and Risk Management Advisory Committee has been renewed for another two years by FDA. The agency said the new expiration date for the panel of external experts is 31 May 2028.

The Psychopharmacologic Drugs Advisory Committee has also been renewed by FDA for two years. The panel of external experts will remain operational until 4 June 2028.

FDA reminded people to sign up for its hybrid meeting on 25 August to discuss patient-focused drug development for nonhealing chronic wounds. More specifically, the agency wants patient perspectives on the impact of nonhealing chronic wounds on their daily life, their views on treatment approaches, factors to consider when selecting a treatment, and what they consider when determining whether to participate in a clinical trial.

AbbVie cancer drug Decnupaz (pivekimab sunirine-pvzy), a CD123-directed antibody and alkylating agent conjugate, was approved to treat adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The agency notes that the application received priority review and that the drug received both breakthrough and orphan drug designations.

AstraZeneca's cancer drug Imfinzi (durvalumab) was approved in combination with Bacillus Calmette-Guérin (BCG), a live, weakened strain of the bacterium Mycobacterium bovis, to treat adults with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). The agency noted that the prescription information includes warnings about immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicities.

Medtech

Endoscopic suturing devices for altering gastric anatomy for weight loss have been downclassified by FDA to class II devices with special controls. The mitigating special controls include clinical and non-clinical performance testing, proper labeling, training, sterilization validation, shelf-life testing, and biocompatibility evaluation.

Transcutaneous electrical nerve stimulators to treat fibromyalgia symptoms have also been downclassified by FDA to class II devices with special controls. The mitigating special controls include biocompatibility evaluation; electromagnetic compatibility testing; electrical, mechanical, and thermal safety testing; non-clinical performance testing; software verification, validation, and hazard analysis; proper labeling; and electromagnetic compatibility testing.

Arrow International has issued a Class I recall for its dialysis catheter kits that include Merit Medical Splittable Sheath Introducers due to a design defect in which the sheath introducer may not split as intended, according to FDA. So far, the company has reported that it has found that two patients were seriously injured due to the defect, but there have not been any fatalities.

Philips has issued a recall for its Trilogy Evo platform of ventilators due to three separate issues associated with using a nebulizer with the devices and an obstruction alarm not triggering as required, according to FDA. The company reported three serious injuries due to the issues but no fatalities.

Erbe USA has issued a class I recall for certain Erbe Flexible Cryoprobes due to reports that a manufacturing issue may cause the products to rupture or burst during activation, according to FDA. The agency reported five serious injuries but no fatalities.

Medline also issued a class I recall for certain Namic Manifolds after finding particulates in the products' fluid path that could cause blockages in blood vessels, according to FDA. The company has asked users to remove and destroy affected Namic Manifolds, but said there have been no reports of serious injuries or death so far.

In more news of particulates found in medical devices, FDA issued an early warning for certain ICU Medical IV tubing sets after the company received reports of black specks and discoloration found on the inner wall of drip chambers, as well as particulate matter found within the drip chambers in certain IV tubing sets. ICU Medical and FDA are investigating the issue and assessing whether it could be biological contamination or if the particulates could enter the fluid path and pose a risk to patients.

FDA also issued an early alert for certain Abiomed Impella CP Sets with SmartAssist because they may be out of specification, leading to low purge pressure and treatment interruptions or loss of mechanical circulatory support. The agency said that as of 7 May, the company has received reports of three pump exchanges that could have led to serious injuries and one potential death.