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.
Tag Archives: 510(k)
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.
Company Ignores FDA’s Request to Cease Commercial Distribution
When FDA says stop, they mean stop!
510(k)s for Reusable Devices Must Include Validated Data for Cleaning in IFUs
Reusable devices have become more difficult to clean, disinfect and sterilize. FDA is now requiring clear instructions for effective reprocessing.
FDA Releases Proposed List of 510(k) Exempt Class II Devices
The agency states this list of more than 1000 devices doesn’t have risks that warrant premarket notification.
Five Steps to Medical Device Commercialization
Bringing a product to market in the United States can be complicated, but it can be streamlined with a clear grasp of the process.
I Changed My Medical Device. Do I Need to Submit a 510(k)?
FDA issues two new draft guidances that explain when device or software changes require a 510(k) submission.
