Speakers at a recent webinar laid out core priorities for federal agencies including the FDA and Department of Justice. Pandemic-related fraud, advertising to children, and corporate compliance programs are among the issues of note.
Data security, clinical trial practices and pandemic-related enforcement will remain priorities for federal agencies in the near future, speakers from the US Federal Trade Commission (FTC) and Department of Justice (DOJ) said at a 27 July webinar sponsored by the Food and Drug Law Institute.
For example, the FTC is still grappling with financial fraud tied to the COVID-19 pandemic, said Christine Lee DeLorme, an...
A recent conference panel discussed the stagnation in diagnostics regulation, highlighting the FDA's failed regulatory efforts on lab-developed tests. Political and legislative challenges hinder other reforms, and concerns over Medicare reimbursement cuts loom for the clinical lab industry.
The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.
Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.
The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.
The US FDA has published a list of recommendations for the safe use of hyperbaric oxygen therapy devices. While the therapy can be effective in treating several conditions, the agency says providers need to understand its potential risks.
Germany’s electronic patient record – ePA – is a flagship initiative of the ongoing national healthcare reform. The medtech industry welcomes rollout of the ePA while calling for further improvements.
EirMed CEO Richard Houlihan warns that EUDAMED (the European database on medical devices) publication delays may harm medical device manufacturers. Currently, only a fraction of the required uploads have occurred, creating potential compliance risks as the mandatory deadline approaches.
