FDA Clarifies Manufacturing Supplements in New Guidance

January 9, 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, issued last month, provides general criteria to help manufacturers determine whether they must submit a special PMA supplement or a 30-day notice for a product modification or manufacturing change.

Special PMA supplements are most appropriate for labeling modifications, but changes to quality control or manufacturing processes might be included in such supplements, the guidance says.
The GMP Letter