News & Insights
Connected Medical Devices and Public Cloud Services
Public cloud computing services are being increasingly used by medical device manufacturers to house components of medical device software. In this post, I am referring to a public cloud as defined by NIST SP 800-145:2011, The NIST Definition of Cloud Computing, and their “platform-as-a-service (PaaS)”…
FDA Resumes Medical Device Inspections – What now?
FDA Resumes Medical Device Inspections It is much more likely that you noticed changes to what the FDA has been doing during the COVID-19 pandemic rather than changes to what it has not been doing. One example of what they have been doing is the review and issuance of Emergency Use Authorizations. …
What Should the Public Know About Implantable Material and Device Innovation in the US?
Abstract Device innovation has potential to improve patient outcomes over time, yet prospective benefits must be considered in light of risks. At the macro level, designers and manufacturers of implantable devices and regulators must balance the need for assurance of devices' safety and effectiveness…
Essential Performance: A Short Story
Why should you care about Essential Performance? Essential performance are equipment specifications that, if one or more fail to be achieved during intended use, the result is the risk of patient harm. If you do not define the essential performance of your product you will not be able to fully claim…
Overview of FDA timelines associated with Traditional 510(k)s
Introduction The Medical Device User Fee Act (MDUFMA) I, signed into law on October 26, 2002, authorized FDA to collect user fees for various marketing applications, including premarket notifications (510(k)s). The fees are intended to be used by FDA on the resources needed to support the review of marking…
Medical Device Breakthrough Designation
With Centers for Medicare and Medicaid Services (CMS) now offering an add-on payment route for breakthrough designated medical devices, it is anticipated that more companies will be submitting requests to FDA for breakthrough designation status. To qualify for breakthrough designation as defined in…
FDA Is Holding Virtual Panel Meetings for Medical Devices
Due to COVID-19, FDA/CDRH is beginning to hold virtual panel meetings for medical devices. On Sept 8-9, 2020, the Orthopaedic and Rehabilitation Devices Panel will meet to discuss the classification of several pre-amendment devices including: facet screws systems, semi-constrained toe (metatarsophalangeal)…
New Policy for SARS–CoV–2 Serology Tests
FDA significantly tightened oversight on SARS‐COV‐2 serology tests by publishing new policy requiring all serology tests to be reviewed and approved under Emergency Use Authorization (EUA). In a rush to make serology antibody tests available as quickly as possible, FDA previously allowed SARSCOV‐ 2…