The FDA July 12 and 13 will hold a public workshop and meeting on "The Essentials of Food and Drug Administration Device Regulations: A Primer for Manufacturers and Suppliers."
FDA
Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Editor's Picks
Additive Orthopedics Announces FDA Clearance of 3D Printed Bone Segments
The segments use a lattice structure to promote bone-in growth instead of older, more open types of structures.
FDA Reference Drug List Flags Companies That Hinder Generics
Some drugmakers refuse to sell samples of products using REMS with Elements to Assure Safe Use (ETASU), affecting distribution to generic competitors, or set conditions for sales that generics companies cannot meet.