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U.S. Department of Health and Human Services

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OCD FY2000: FDAMA implementation


We are now in our third year of implementing the FDA Modernization Act of 1997 (FDAMA). During the first two years of FDAMA, we issued a large number of guidance documents and final rules to implement its various provisions. With this year’s efforts, we have continued to revise and update previous documents, where appropriate, and we have focused on more complex and far-reaching issues.

  • Six-year Data Provision
We issued a guidance document to resolve conflicting interpretations of Section 216 of FDAMA. This section governs the circumstances under which the agency can use data in one PMA to establish the safety or effectiveness of any device other than the one for which the data were submitted (this includes more than PMA approval, e.g., down classification).
  • Accredited Persons Review Program
We are working with the medical device industry to increase the use of third party review of low to moderate-risk devices. During the first 17 months of the FDAMA Accredited Persons program, third parties reviewed only 54 510(k)s. In June 2000, we updated the list of devices eligible for third party review, immediately adding 57 devices for a total of 211. At the same time, we proposed procedures for an expansion pilot program that would add another 460 devices--overall, more than a 300 percent increase. Currently, we are considering comments received on the proposed procedures and will issue final guidance on implementation of the expansion pilot program in early 2001. In addition, we have prepared a Report to Congress that recommends deferral of a decision on removing the statutory exclusion of devices with clinical data from the program.
  • Medical Devices Dispute Resolution Panel
Les Weinstein was appointed as our Center’s first Ombudsman and permanent members were recruited for the Medical Devices Dispute Resolution Panel. Mr. Weinstein, who reports directly to the Center director, investigates complaints from outside FDA, and facilitates the resolution of disputes between CDRH and the industry it regulates. The Dispute Resolution Panel had its inaugural meeting in October. Final guidance is being prepared that will provide detailed information on bringing disputes before the panel.
  • Least Burdensome Path to Market Devices
Our goal is to get the right information to support submissions – not more, not less. We formed a CDRH-wide working group on least burdensome issues, created a dedicated webpage to consolidate information, used our first CDRH-wide webcast to engage staff on this important topic, and have conducted training for staff and Advisory Panel Members. We’ve also changed many of our internal tracking documents and correspondence with companies to highlight least burdensome efforts. Working collaboratively with an Industry Task Force, we prepared a "Concepts and Principles" document. Efforts are continuing, both internally and with the Industry Task Force, to implement the least burdensome provisions in all of our activities.