Newsletter - October 4, 2018
FDA Prioritizes Digital Health for 2019
The list of planned Guidance Documents is a good indicator of FDA’s priorities for the coming year. Each year each center at the FDA publishes the list of Guidance Documents it plans to publish or draft next year. CDRH’s list of Guidance Documents shows that software-based products are the top priority of the Center this year... Read More
FDA Expands the Special 510k Process
Traditionally, when making changes, updates or improvements to Class II devices approved under the 510k process, the developers had to file a new traditional 510k for the updated device. Under a pilot program launched earlier this week, FDA expanded the special 510 process...Read More
FDA Prioritizes Digital Health for 2019
The list of planned Guidance Documents is a good indicator of FDA’s priorities for the coming year. Each year each center at the FDA publishes the list of Guidance Documents it plans to publish or draft next year. CDRH’s list of Guidance Documents shows that software-based products are the top priority of the Center this year... Read More
FDA Expands the Special 510k Process
Traditionally, when making changes, updates or improvements to Class II devices approved under the 510k process, the developers had to file a new traditional 510k for the updated device. Under a pilot program launched earlier this week, FDA expanded the special 510 process...Read More
