- The FDA has deemed Hamilton Ventilators’ recall of its C1, C2, C3, T1 ventilators as class I, as the company has received reports of software issues that may cause the ventilators to stop without notice, with the potential for serious injury or death.
- The lot passed sterility testing but another in the same cleaning cycle failed.
- As lawmakers fail to reach a deal to extend funding past the critical deadline of Sept. 30, the possibility of a government shutdown looms, threatening operations at the FDA and other government agencies.
- Artificial womb technology aims to bridge the period between extreme preterm birth and later gestation.
- Medline Industries’ recall of 18,000 saline solution vials due to being non-sterile has been deemed as class 1 by the FDA, the most serious type of recall, because use of the device may cause serious injuries or death.
- The FDA is working on cultivating educational resources on AI/ML for stakeholders.
- Much needs to be hammered out before the FDA can comfortably green light first-in-human studies of artificial womb devices for extremely premature infants, said several members of the FDA’s Pediatric Advisory Committee (PAC) on Tuesday.
- The FDA has expanded the scope of its guidance on conducting clinical trials during the COVID-19 pandemic to apply to public health emergencies (PHE) and other disasters, issuing final guidance that also includes several clarifications.
- CDRH, as part of its MDUFA V commitments, has released a draft plan to further its work toward globally harmonized medical device regulation, policy and practices as part of the effort to reduce redundant expectations and requirements among international regulatory bodies.
- The artificial womb aims to bridge the period between extreme preterm birth and later gestation.
- Applications that use AI and machine learning (ML) have a unique dependence on data, said the FDA’s Digital Health Center of Excellence Acting Deputy Director MiRa Jacobs at Tuesday’s open forum held by the Alliance for a Stronger FDA.
- The FDA has released a draft guidance on how it intends to determine whether sponsor-provided prescription drug software output should be treated as FDA-required labeling or promotional labeling and how, or if, the corresponding software function should be described in the prescribing information (PI).
- An updated HHS policy will include specific provisions prohibiting political interference.
- The best way to design trials around an artificial womb intended to better regulate body temperature and foster safer lung development in extremely premature infants (EPI) is the focus of the FDA’s Pediatric Advisory Committee (PAC) as they meet on Tuesday and Wednesday of this week.
- Drugmakers misused Orange Book listings to improperly protect patents.
- The association said that they have seen lawyer-funded and investor-backed advertising mislead patients into seeking legal action for non-faulty devices.
- On Thursday, the FTC voted unanimously (3-0) to issue a policy statement warning pharmaceutical companies that they could face legal action for improperly listing patents in the FDA’s Orange Book in an attempt to stave off competition.
- This special edition of Quick Notes covers FDA issuance of final guidance for the Breakthrough Device Program, drug postmarketing requirements and commitments and the CDRH voluntary improvement program as well as draft guidances on clinical study design and non-clinical testing of weight loss devices.
- The agency considers the extent of consumer injury, financial and physical, when determining how to allocate their resources.
- Our coverage spans relief from third party funded mass tort litigation sought by the medical device industry to Apple prevailing in Masimo patent appeal and two class I device recalls.