FDA Submissions

MDRA provides guidance and assistance in preparation and submission of pre-market notification 510(k) and PMA applications by performing:

• Regulatory Strategic Plans and Product Classification Assessment
• Traditional, Special and Abbreviated 510(k) Pre-Market notification
• Pre-Market Approvals
• Clinical Studies
• Establishment Registration
• Product Listings
• US Agent Services

Regulatory Assessment

We will review the existing product technical file and other product information to determine the documents required for submission of the 510(k) or PMA, and verification of the FDA classification.   Based on the technical information and the FDA classification, we will determine the FDA regulations and standards that apply, and the product testing which is required for clearance.   Any uncertainties will be discussed with the FDA review staff, and agreed upon with your company before the submission strategy is finalized and the submission started.

510(k) or PMA Submission

We then will draft the submission, based on the technical file, supporting documentation, test reports, proposed labeling, and other required information.   We will provide forms for the necessary certification and declarations, ready for signature.   The submission will be formatted, printed, and delivered to FDA after company approval.   All documents submitted to FDA must be in English.   However, MDRA can arrange translation services, at an additional fee.

Submission Support

During the time the submission is in review, we will respond to any questions and provide any additional information requested.   R equests for additional information and supporting documents are common.   This can often extend the review period and timely response is critical.