Medical Device User Fee and Modernization Act

The FDA are allowed 90 days to review a Traditional or Abbreviated 510(k) notification, and just 30 days for a Special 510(k). With the introduction of the Medical Device User Fee and Modernization Act of2002, provision was made for the participation of third-party organisations in the review process. This represents a partial adoption of the concept of Notified Bodies, which prevails in Europe. The FDA have accredited a number of commercial organisations to conduct primary 510(k) reviews of670 types of device. The FDA must then give a final determination within 30 days of receipt of the recommendation of a third-party reviewer. Because they are commercial, third-party reviewers will seek to offer faster review times in return for their review fee. If using a third-party reviewer, the FDA user fee does not apply. The outcome of a successful 510(k) notification is a letter from the FDA clearing the device for commercial sale. 

To address these concerns, a new OCP was created on December 24, 2002 as part of the Medical Device User Fee and Modernization Act (MDUFMA) of 2002 [8. Department of Health and Human Services, Food and Drug Administration, 21 CFR Part 3. Assignment of Agency Component for Review of Premarket Applications. Final rule. Federal Register. Vol. 68, No. 120, Monday, June 23, 2003 http //www.fda.gov/oc/ combination/section204.html (accessed October 2005).]... 

The Medical Device User Fee and Modernization Act (MDUFMA) amended the Federal Food, Drug and Cosmetic Act to provide the FDA with important new responsibilities, resources, and challenges [7]. The MDUFMA has three significant provisions (1) Premarket Approval Applications (PMAs), Product Development Protocols (PDPs), Biological License Applications (BLAs), certain supplements, and 510(k)s are now subject to fees. (2) Establishment inspections may be conducted by... 

The Office of the Combination Products was established under the aegis of the Medical Device User Fee and Modernization Act of 2002. This office has responsibilities over the regulatory life cycle of combination products, and (1) assigns the FDA Center for primary review jurisdiction of the product (2) works with FDA Centers to develop regulatory guidance and clarify regulation of these products and (3) serves as a focal point for combination product-related issues for internal and external stakeholders. 

Medical devices were first made subject to FDA regulation under the FD C Act of 1938. At that time, the statute included no requirement for premarket testing or approval. Congress enacted the Medical Device Amendments of 19766 to require pre-market notification for all medical devices, and pre-market approval for some old and new devices for which there is no adequate assurance of safety and effectiveness. The 1976 Amendments established a broad new array of statutory requirements and enforcement provisions. This new regulatory approach was supplemented by the Safe Medical Devices Act of 1990 3 and further refined by the Medical Device Amendments of 1992,61 Food and Drug Administration Modernization Act of 1997,6 jj g Medical Devise User Fee and Modernization Act... 

The FDA Modernization Act took the Prescription Drug User Fee Act and expanded it to improve and speed up the approval process for new drugs and devices. A fast track approval process was implemented for serious or life-threatening disease products that demonstrated the potential to address unmet medical needs. Inactive ingredient labeling requirements were implemented for... 

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