2016 FDA Guidance Documents You Should Know
These were the most important guidance documents of the year for medical device manufacturers.
4 Tips for a Smooth 510(k) Submission Process
As you are probably aware, a 510(k) submission is required in order to get FDA market clearance for nearly all Class II devices.
Read More
10 Biggest Medical Device Recalls of 2016
2016 was a big year for medical device recalls, with the number of units recalled in the third quarter reaching the highest level in four years. Here are the 10 recalls that impacted the most medical device units in the United States.
Read More
Two Big Moves at FDA
FDA launched two major initiatives in 2016—cybersecurity requirements and a national system for real-world device monitoring.
Read More
Protecting Software as a Medical Device
Patent protections for Software as a Medical Device are increasingly important due to the additional investments in clinical evaluation that may be needed to withstand the FDA scrutiny under the new draft guidelines.
Read More
