Should you use an FDA eCopy or an FDA eSTAR to respond to FDA deficiencies?

Most 510(k) and De Novo submissions are placed on hold when the FDA requests additional information. This happens about 99% of the time. Typically, there will be 10-20 questions to respond to. You have 2 options for responding to the request for information:
1. revise your eSTAR and resubmit with the additional information
2. create an eCopy and submit the eCopy to the FDA with only the additional information

The eCopy is generally a little faster to prepare, and the FDA accepts either approach. So why should you consider the eSTAR route:
1. it gives you more practice with the eSTAR and will help you long-term if you submit regularly
2. it keeps all of the information organized in one place (this is preferred by the FDA, and it will help you when you submit your next generation product in 1-2 years)
3. it eliminates any potential for your response being placed on eCopy hold

Regardless of which approach you choose, your response still needs to be organized with each request from the FDA followed by your response to the FDA's request.