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ARM requests additional clarity on a number of points within the guidance and recommends the FDA hold a public hearing to facilitate discussion with stakeholders. WASHINGTON,
RALEIGH, N.C., Feb. 23, 2015 /PRNewswire/ -- BioDelivery Sciences International, Inc.
Each year, the U.S. FDA conducts thousands of routine facility inspections.
The FDA has decided that it will not regulate a class of low-risk products it calls general wellness products.
Cost-effective, high-quality production of API using microbial expression systems BOONTON, N.J., Feb.
A recent analysis of 2014 Form 483s issued to devicemakers found that purchasing control violations were up 17% over 2013. Join FDAnews on Feb.
Compliance with IEC 62304 is required for all electromedical devices where basic safety is dependent on software or firmware.
On Dec. 22 and 23 the FDA released two important guidances regarding the management of human cells, tissues and cellular/tissue based products (HCT/P). Join FDAnews on Feb.