Regulatory Focus

Notified body association Team-NB has suggested changes to the European Commission’s proposals for risk-adaptive surveillance of medical devices.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The US Food and Drug Administration (FDA) recently warned a distributor and medical device maker for marketing continuous positive airway pressure (CPAP) machines and related software for treating sleep apnea without securing proper marketing authorization and for inadequate complaint handling. The agency also warned a device maker for misclassifying its products as premarket notification exempt pharmacy compounding kits.

Industry and academic stakeholders have asked the US Food and Drug Administration (FDA) to clarify its objectives and plans for a proposed pilot program to evaluate how artificial intelligence (AI) technologies can help improve early-phase clinical trials. They also said the agency should develop a governance structure with specific metrics and goals and consider aligning its thinking with other regulators.

The European Commission has published two delegated acts that expand the list of well-established technologies (WET) under the Medical Devices Regulation (MDR) that are exempt from conducting clinical investigations and technical assessments. The first regulation applies to implantable devices and Class III devices, while the second regulation focuses on Class IIb implantable devices.

The US Food and Drug Administration (FDA) has issued warning letters to several drugmakers for violations of current good manufacturing practices (CGMP). The agency also issued a warning letter to a Chinese drugmaker for marketing drugs in the US without providing regulators with the critical records needed to ensure compliance.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Officials from the US Food and Drug Administration (FDA) and pharmaceutical industry representatives could not reach an agreement on the number of reference product exclusions (RPE) to make each year, and agreed to table the issue until another meeting, according to the minutes from a recent discussion on reauthorizing the Biosimilar User Fee Act (BsUFA).