FDA / EU MDR / Regulatory News
With the Pre-Cert program, the agency first examines the software or digital health technology developer rather than the device. Companies that demonstrate culture of quality and organizational excellence will be able seek a streamlined review of SaMD (Software as Medical Device) products. As part of pre-certification process, FDA will conduct Excellence Appraisals that will be based on patient safety, product quality, clinical and cybersecurity responsibility and proactive culture. Pre-certified firms would be able to market lower-risk devices with either a streamlined review or no premarket review such as 510(k) etc.
The Agency will continuously assess and evaluate the readiness of the Pre-Cert Program before progressing to the next phases of development and will consider obtaining legislative authority to fully implement it as a new pathway for SaMD. No timeline is provided.
Nine firms are currently participating in the Pre-Cert pilot: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily
The Digital Health Center of Excellence (DHCoE) is part of the planned evolution of the Digital Health Program in the Center for Devices and Radiological Health (CDRH) and will align and coordinate digital health work across the FDA. According to the FDA, it marks the beginning of a comprehensive approach to digital health technology, setting the stage for advancing and realizing the potential of digital health.
The DHCoE provides regulatory advice and support to the FDA’s regulatory review of digital health technology and is not responsible for making marketing authorization decisions.
It provides services in the following functional areas for digital health:
- Digital Health Policy and Technology Support and Training
- Medical Device Cybersecurity
- Artificial Intelligence / Machine Learning
- Regulatory Science Advancement
- Regulatory Review Support and Coordination
- Advanced Manufacturing
- Real World Evidence and Advanced Clinical Studies
- Regulatory Innovation
- Strategic Partnerships
Cybersecurity
German authorities said that an apparently misdirected ransomware attack caused the failure of IT systems at a major hospital in Duesseldorf, and a woman who needed urgent admission died after she had to be taken to another city 20 miles away for treatment.
The hospital said investigators have found that the source of the problem was a hacker attack on a weak spot in “widely used commercial add-on software,” which it didn’t identify. A report said that 30 servers at the hospital were encrypted last week and an extortion note left on one of the servers although the note didn’t name any sum.
This may be the first confirmed death resulting from a cyber-attack on healthcare infrastructure.
