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Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission

The FDA’s announced on November 21, 2003, guidelines on how companies can bundle multiply devices or multiple indications for use into a single submission, whether that submission is a 510(k) or PMA.

This guidance is being issued because of the extra costs being imposed by the FDA user fees. Companies are becoming very creative in how they are putting their 510(k) together for FDA submission. With the FDA User Fees of $3480. for each 510(k) and for the PMAs it is $206,811. ( though there are reductions for first time and for small businesses ), companies are starting to fee the pinch of making applications to the FDA.

It was only a matter of time for the FDA to address the issue being posed by the industry of device bundling.

This guidance document provides some answers to your possible questions and though it cannot answer all your questions, it supplies a good starting place.

The entire document can be reviewed at http://www.fda.gov/cdrh/mdufma/guidance/1215.html

For more information on device bundling and to help with your 510(k) applications please contact us at info@mdiconsultants.com

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