The FDA is reopening the comment period for the “Voluntary Medical Device Manufacturing and Product Quality Program” Public Workshop until December 14, 2017.”
On Tuesday, October 10, 2017, the FDA held a public workshop to announce the proposed framework and preliminary outline of a voluntary pilot program that recognizes an independent assessment of design, manufacturing and product quality among medical device manufacturers. Using independent performance evaluations, the voluntary pilot program seeks to identify quality-focused measures taken by manufacturers who have demonstrated good compliance history as they design and manufacture their medical devices.
This workshop presented an opportunity for industry, patients, government and academic partners, and payer/provider counterparts to discuss: the framework of the voluntary pilot program, information on the independent assessment that will be part of it, details of participation, rules of engagement, monitoring and performance expectations, and potential modifications to FDA's oversight activities in response to demonstrated manufacturing quality performance. The information resulting from the pilot program will ultimately be used by the FDA and its stakeholders to help other medical device manufactures strengthen their products and manufacturing quality.
Electronic comments can be submitted following the instructions found in the Federal eRulemaking Portal at: https://www.regulations.gov. Written comments should be sent to:
Division of Dockets Management (HFA-305)For comments containing confidential information, please follow the instructions found in the Federal Register Notice for this event.
Food and Drug Administration
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Food and Drug Administration
Center for Devices and Radiological Health
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