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# New FDA Medical Device Initiatives Under MDUFA
- URL: https://www.fdaweb.com/new-fda-medical-device-initiatives-under-mdufa/
- Published: 2018-08-16T12:00:00.000Z
- Updated: 2026-09-15T00:26:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142126

FDA says it is launching three new initiatives under the recent MDUFA reauthorization to support medical device development, innovation, and safety. The first [change](https://www.federalregister.gov/documents/2018/08/17/2018-17770/medical-devices-and-device-led-combination-products-voluntary-malfunction-summary-reporting-program?ref=fdaweb.com) is the Voluntary Malfunction Summary Reporting Program under which manufacturers will be able to report certain medical device malfunctions in a quarterly summary rather than individually. The notice provides specific product codes for devices that will be eligible for summary reporting. “The goal of the Voluntary Malfunction Summary Reporting Program is to permit manufacturers of devices under certain product codes to report malfunctions on a quarterly basis and in a summary format … in a manner that provides for effective monitoring of devices and is beneficial for FDA, industry, and the public,” the agency says.

The second [initiative](https://www.federalregister.gov/documents/2018/08/17/2018-17731/medical-devices-classification-of-accessories-distinct-from-other-devices-proposed-list-of?ref=fdaweb.com) starts the process of requesting comments on a proposed list of medical device accessories for which FDA believes that general controls will provide a reasonable assurance of safety and effectiveness and which it may classify as Class 1, low-risk devices. “Finalizing the list of accessories suitable for classification into Class 1 will reduce the regulatory burden for those devices and help support the agency’s risk-based approach so that resources can be better focused on the products that pose the most risks to patients,” the agency says.

Finally, a draft [guidance](https://www.federalregister.gov/documents/2018/08/17/2018-17796/guidance-process-to-request-a-review-of-food-and-drug-administrations-decision-not-to-issue-certain?ref=fdaweb.com), *Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices*, will explain the denial process for certificate to foreign government requests for medical devices exported from the U.S. FDA says the guidance clarifies the reasons that the agency may deny a certificate request and tells the information that it will provide to a firm whose certificate request has been denied, as well as the process for requesting a review of the agency decision. The guidance applies only to certificates for devices that are approved or cleared for marketing in the U.S. or are exempt from premarket submission requirements.