When Congress reauthorized MDUFMA it also established a more aggressive set of performance goals. To meet these goals, both the FDA and regulated industry agreed to a more formalized interactive review process to encourage and facilitate communication between FDA staff and industry. The process is for review of premarket notification submissions (510(k)s), original premarket approval applications (PMAs), and PMA supplements.

The interactive review process calls for more informal interaction between FDA and applicants, including the exchange of scientific and regulatory information. The interactive review process is intended to prevent delays, clearly communicate the FDA's concerns to applicants, minimize the number of review cycles, and ensure timely responses from applicants.

To ensure an efficient interactive review, the FDA suggests the following guidelines:

• A complete submission should be consistent with applicable regulations, recommendations in the available guidance documents, and communications with FDA prior to submission.

• Provide complete contact information in the cover letter accompanying each formal submission.

• Apply appropriate material or testing standards and submit the necessary declarations or data to support the use of the standards.

• Provide a complete response to all deficiencies communicated informally during a review cycle within the FDA-allotted timeframe.

• Provide a complete response to all deficiencies cited in a formal hold letter within the specified timeframe in the letter, including reasons for responding in a different manner from that requested by FDA.