At Long Last: FDA Updates Software Guidance (Part II of II)
As noted in Part I, last week the FDA released a long-awaited updated guidance document regarding the Content of Premarket Submissions for Device Software Functions. This…
At Long Last: FDA Updates Software Guidance (Part I of II)
On November 4, 2021, the FDA released a long-awaited updated guidance document regarding the Content of Premarket Submissions for Device Software Functions. This guidance, the first…
New FDA Guidance Regarding Bench Testing
The FDA has recently posted new guidance regarding bench testing. FDA suggests including both test report summaries and complete test reports, when appropriate. Complete test reports…
FDA Digital Health Center of Excellence Listening Sessions
The two sessions were moderated by Bakul Patel | Director for the Digital Health Center of Excellence (DHCoE) On September 22, 2020, the FDA established the…
Software Development Process for Healthcare Applications
Summary of Key Points Software development process require a variety of process planning activities that would address how you design, implement, and maintain software throughout its…
Documentation impacted by EU MDR
For medical device companies selling in the EU, the May 2020 deadline for Europe’s new Medical Device Regulation 2017/745 (MDR) is coming up soon. Post this…
Enforcement Policy from the FDA to combat COVID-19
Link to the Policy Document: https://www.fda.gov/media/136290/download As the COVID-19 situation is getting more serious all over the world, FDA issued an enforcement policy for non-invasive remote…
Enforcement Policy — Digital Health Devices For Treating Psychiatric Disorders During COVID-19
Link to the Policy Document: https://www.fda.gov/media/136939/download The FDA recently put out a new enforcement policy for digital health devices treating psychiatric disorders during the COVID-19 Public…
The Essentials: Regulatory requirements for medical device software
Summary of Key Point The key to address medical device software regulation starts with three questions: What does your software do? How do you plan to…
How do startups leverage FDA’s Pre-Cert Working Model – Part 2
This is Part 2 of a two-part series focusing on FDA's Pre-Cert Working model. 4. Streamlined Review: It is expected that software products that are considered…