www.fdanews.com/articles/113772-fda-clarifies-manufacturing-supplements-in-new-guidance
FDA Clarifies Manufacturing Supplements in New Guidance
January 15, 2009
The FDA is recommending that devicemakers carefully assess which submission they need to file when they change manufacturing procedures for a product — either filing a 30-day notice or a special PMA supplement. A final guidance, which was issued last month, provides general criteria to help manufacturers determine which submission is necessary when modifying their product or changing a manufacturing process.
The GMP Letter
The GMP Letter