Newsletter - October 7, 2021
FDA’s Final Rule for De Novo Classification: Mostly Unchanged Process
This week FDA published the final rule for the De Novo classification request for novel medical devices keeping the process mostly same as the previous rule. The process still requires that the applicant submit a detailed De Novo Class I or II designation request after the 510k application has been rejected or no predicate exists...Read More
FDA’s Tip on Communicating Cybersecurity Issues to Patients: Keep it Simple
When FDA, industry, or any other stakeholder (collectively called the “messengers”) become aware of any cybersecurity vulnerabilities in a medical device connected to the internet, they must inform the patients and caregivers (collectively called the “users”) in an easy to find, read and understand communication on the internet....Read More
FDA’s Final Rule for De Novo Classification: Mostly Unchanged Process
This week FDA published the final rule for the De Novo classification request for novel medical devices keeping the process mostly same as the previous rule. The process still requires that the applicant submit a detailed De Novo Class I or II designation request after the 510k application has been rejected or no predicate exists...Read More
FDA’s Tip on Communicating Cybersecurity Issues to Patients: Keep it Simple
When FDA, industry, or any other stakeholder (collectively called the “messengers”) become aware of any cybersecurity vulnerabilities in a medical device connected to the internet, they must inform the patients and caregivers (collectively called the “users”) in an easy to find, read and understand communication on the internet....Read More
