BioWorld. Link to homepage.
BioWorld
BioWorld MedTech
BioWorld Asia
BioWorld Science
Data Snapshots
BioWorld
BioWorld MedTech
Infographics: Dynamic digital data analysis
Special reports
Aging
Alzheimer's disease
Artificial intelligence
Biosimilars
Coronavirus
Infographics: Dynamic digital data analysis
Israel
IVDs on the rise
Radiopharmaceuticals
Rise of obesity
Top Biopharma Trends of 2023
Top Med-tech Trends of 2023
Top Preclinical Trends of 2023
Premium reports
BioWorld Financings Reports
Disease Incidence & Prevalence Summaries
BioWorld. Link to homepage.
sign in
Sign Out
My Account
Subscribe
BioWorld - Friday, April 19, 2024
See today's BioWorld MedTech
Home
» New FDA draft guidance seen as vital for digital companies new to regulation
X
Upgrade your daily dose of biopharma and medtech news
Subscribe to BioWorld™ news services
See subscription options
To read the full story,
subscribe
or
sign in
.
New FDA draft guidance seen as vital for digital companies new to regulation
Nov. 12, 2021
By
Mark McCarty
No Comments
The FDA’s device center has revisited the 2005 guidance for the content of premarket submissions for device software functions, a document that puts much more emphasis on risk compared to the legacy 2005 guidance.
BioWorld MedTech
Regulatory
Digital health
SAMD
U.S.
FDA