FDA Issues Draft Guidance for Medical Device Pre-Submission Program

Jul 20, 2012   
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On July 13, 2012, the U.S. Food and Drug Administration (“FDA“) issued a Draft Guidance document entitled “Medical Devices: The Pre-Submission Program and Meetings with FDA Staff” (“the Guidance”). The Guidance outlines the Agencys recommendations and procedures for medical device manufacturers and researchers who want early feedback and advice before submitting product- or research-specific applications. When final, the Guidance will supersede the 1999 guidance entitled “Pre-IDE Program: Issues and Answers – Blue Book Memo D99-1.” 

The Guidance expands on the pre-Investigational Device Exemption (“pre-IDE”) program and will now be referred to as the Pre-Submission (“Pre-Sub”) program. The pre-IDE program allows applicants to obtain feedback on a product during the investigational stage and prior to the formal application process. The Pre-Sub program broadens the pre-IDE program to include Premarket Approval (PMA), Humanitarian Device Exemption (HDE), Premarket Notification (510(k)), and de novo submissions.

The FDA states that the Pre-Sub program will provide more timely regulatory actions and innovative new devices for patients through improved submissions. The Guidance advises applicants how to improve their pre-market submissions by:

  • describing when device developers might benefit from early FDA feedback;
  • describing pre-submissions package content necessary for optimal FDA feedback: and
  • explaining how to best engage FDA in informal meetings to discuss the most efficient path with a new technology or  planned regulatory submission 

The FDA cautions that the Pre-Sub program is not an alternative to traditional approval and clearance processes. Instead, the Pre-Sub program is intended to help industry identify regulatory requirements early in the device development process to facilitate earlier, more transparent, and more predictable interactions with the FDA. The Guidance stresses that the Pre-Sub program is designed to answer specific questions an applicant may have during product development.

The Pre-Sub program is part of the FDAs effort to strengthen its image regarding the safety of medical device products after facing criticism regarding the 510(k) program. Last year, the Institute of Medicine (“IOM”) released a report which assessed the overarching structure of the 510(k) process and its ability to sufficiently monitor and oversee the safety and efficacy of medical devices on the market. Overall, the IOM identified substantial problems with the FDAs 510(k) process and suggested the FDA integrate a premarket and post-market regulatory framework that provides for reasonable assurance of safety and effectiveness throughout the device life cycle. Please see our previous report for more information regarding the IOM report.

The medical device industry has also criticized the FDAs medical device review process. For years industry has complained about slow FDA review. The Pre-Sub program is expected to improve review times due to improved submission quality from applicants. The FDA states that the Pre-Sub program will provide industry with enhanced predictability and transparency during the medical device review process.   

However, the FDA notes that its ability to hold timely meetings is contingent upon its resources, which are often strained. The FDA estimates that it will receive approximately 2,544 pre-submission meeting requests annually. Each meeting request is estimated to involve 137 hours of work per applicant. Thus, the extent of the effect of the Pre-Sub program on review times remains to be seen.

Anyone can submit comments on the Guidance at any time. However, in order to ensure that the FDA considers comments on this Guidance when developing the final guidance, electronic or written comments should be submitted by October 11, 2012. Electronic comments should be submitted here. Written comments should be submitted to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

The FDAs review of medical devices is complex. Fuerst Ittleman has extensive experience successfully navigating medical devices through FDA review. For more information on FDAs review of medical devices, please contact us at contact@fidjlaw.com.