Policy & Regulation

The director of the US FDA’s device center is sounding the alarm on the scarcity of critical devices for pediatric patients and says the agency is focused on solutions to this “unique” challenge.

Member states reported 309 significant cybersecurity incidents affecting the healthcare sector in 2023 – more than in any other critical sector.

The long-awaited post market surveillance regulation for medical devices on the Great Britain market will come into force on 16 June.

The European Commission has issued a report on the protectionist medtech policies in China that are impacting imports and is considering measures to protect EU manufacturers.

The director of the US FDA’s device center is sounding the alarm on the scarcity of critical devices for pediatric patients and says the agency is focused on solutions to this “unique” challenge.

The US FDA has published warning letters to device firms Integra and Hologic. Both letters recount quality systems issues, with Integra’s centering on sterility while Hologic’s addresses a delay in noting safety signals from the company’s recalled BioZorb markers.

The draft guidance clarifies that sex and gender are not interchangeable, but could be vulnerable in the Trump Administration as Republicans have argued against transgender medical care and that sex and gender must be congruent.

While the US FDA will not require diversity action plans for clinical trials for a while, some companies are already sending them in, a new FDA report to Congress shows.

A failure to properly route cardiac events has led Philips to recall its heart monitoring software that interprets ECG data. Multiple injuries and two deaths are associated with the problem.

The Therapeutic Goods Administration is advising companies to get up to speed with its new recall procedure, which is designed to improve the timeliness of recalls, alerts and corrections, and reduce regulatory burden for sponsors.

The settlement with the SEC closes out safety issues around the company’s Alaris infusion pumps. BD reportedly failed to alert investors or the FDA of known problems with the infusion pumps’ software for several years.

After raising $68m series B funding in September, Neo Medical's announced on 2 December that its entire product portfolio has secured EU MDR approval. Co-CEO and founder Vincent Lefauconnier explained the rationale to Medtech Insight.

The US Senate is considering a bill to expand Medicare coverage for breakthrough devices and diagnostics, removing the five-per-year limit imposed by CMS’ Transitional Coverage for Emerging Technology (TCET).

This week, the US device center announced a pilot program to speed communications about high-risk recalls; Cardinal paid $3.9B for Advanced Diabetes Supply Group and GIA Alliance; a companion diagnostic for Merck lung cancer drug Tepmetko got FDA clearance; and more.

The US FDA has increased the number of devices cleared through its breakthrough program, which the agency established in 2015 to expedite access to products aimed at treating life-threatening and debilitating diseases.

The director of the US FDA’s device center is sounding the alarm on the scarcity of critical devices for pediatric patients and says the agency is focused on solutions to this “unique” challenge.

The US FDA has finalized guidance on notifying the agency of potential device shortages during or prior to a public health emergency. The document includes a list of devices that manufacturers must notify the FDA of when they are in short supply. The guidance also clarifies that device makers voluntarily notify the agency of potential supply chain disruptions at any time.

The medtech industry played a pivotal role in the first Trump administration, most notably during the COVID-19 pandemic. But the sector was also impacted by the administration’s deregulation push and trade posture towards China, including tariffs. So, should stakeholders expect more of the same in a second Trump term, or brace for uncertainty and change?

A US House Oversight Committee report criticizes the government's COVID-19 response, including PPE shortages and issues with the CDC’s test development process. However, it praises the successful public-private partnerships in developing diagnostics, emphasizing the importance of leveraging private industry expertise for future pandemic preparedness.

Attorneys with law firm Gibson Dunn believe that fewer investors will be investigated for False Claims Act violations under the incoming Trump administration but expect other policy to go full steam ahead.

Despite questions surrounding the SEC rule, including disputes being litigated in the US Eighth Circuit, companies must prepare to meet the new climate disclosure requirements in addition to related mandates in California and abroad. Experts emphasize opportunities beyond compliance.

As the 6 May deadline to implement the FDA’s final rule on lab-developed tests approaches, attempts to stop the rule from taking effect are set to play out in court. A panel of experts discussed the potential impact of these legal efforts, should they be successful, at the Medtech Conference in Toronto.

The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.