CDRH Prepares to Take On 2022 While Managing Unprecedented Workload
The center is also hoping to move back into more normal review timelines next year.
Tag Archives: 510(k)
The Regulatory Aspects of AI/ML-based SaMD
Modern technology has given rise to new legal questions. How does FDA regulate machine-learning computers that are changing so rapidly – given that the approved product may be drastically different than the product that ends up on the market? These questions arise from a lack of understanding of the complex nature of AI/ML-based SaMD, the opaqueness of the regulatory framework, and a dearth of relevant case law.
Does Your Class II Device Qualify for a 510(k) Premarket Notification Exemption?
The exemption reduces the regulatory burden on the medical device industry—including the time and costs involved in preparing, submitting and responding to requests for additional information.
FDA Clears Abbott’s Continuous Glucose Monitoring System for Use in Children
The FreeStyle Libre 2 now has indications for children ages four and older.
How Effective Collaboration Can Expedite Medical Device Design
Medical device companies are committing significant resources to the fight against Covid-19. Collaboration tools can help expedite product design while supporting evolving compliance standards.
FDA Reclassifies Image Analyzers from Class III to Class II Devices
Special controls are also provided for reasonable assurance of the safety and effectiveness of the devices impacted by the reclassification.
Developing a Mobile Medical Device? FDA Is Watching
Designers and manufacturers of both devices and software must conduct due diligence and ensure regulatory compliance in protecting user data.
510(k) Guidance Shifts Away Substantial Equivalence in Favor of Performance Testing and Criteria
This new pathway is a considerable change for the medical device industry.
FDA Issues Guidance on 510(k) Exemption of Certain Low-Risk Devices
The agency’s intent is to decrease regulatory burden while promoting patient access to products.
FDA Encourages Innovation and Safety as Part of Medical Device Regulatory Overhaul
The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.
