The Food and Drug Administration (FDA) joins the Medical Device Single Audit Program’s Regulatory Authority Council in encouraging medical device manufacturers to participate in the Medical Device Single Audit Program (MDSAP) Pilot. The Medical Device Single Audit Program is expected to begin transition to full implementation on January 1, 2017.
What is Medical Device Single Audit Program (MDSAP)?As envisioned by the International Medical Device Regulators Forum (IMDRF), the FDA developed MDSAP in collaboration with regulatory authorities from Australia, Brazil, Canada, and Japan. IMDRF recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.
MDSAP enables medical device manufacturers to contract with an MDSAP-authorized Auditing Organization (AO) to conduct a single audit against the relevant medical device regulatory requirements of all fully participating regulatory authorities. For more information about the Medical Device Single Audit Program, please visit the FDA MDSAP Pilot Webpage.
In an effort to help inform the medical device manufacturing community about MDSAP, the FDA posted ten new medical device education modules to the CDRH Learn Program website.
What is CDRH Learn?CDRH Learn is a multimedia catalog of online educational modules intended to provide information about medical device laws, regulations, and policies that is comprehensive, interactive, and easily accessible. The format for each topic is chosen to present the information in the most effective way possible.
New MDSAP ModulesTen new modules can be found in the “Postmarket Activities” section of CDRH Learn.
CDRH Learn Module Title | Key Learning Objective(s) |
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1. Introduction to MDSAP |
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2. MDSAP Management |
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3. MDSAP Device Marketing Authorization and Facility Registration |
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4. MDSAP Measurement, Analysis and Improvement |
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5. MDSAP Medical Device Adverse Events and Advisory Notices Reporting |
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6. MDSAP Design and Development |
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7. MDSAP Production and Service Controls, part 1 |
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8. MDSAP Production and Service Controls, part 2 | |
9. MDSAP Production and Service Controls, part 3 | |
10. MDSAP Purchasing |
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DisclaimerThese CDRH Learn Modules are available for informational purposes only. They are not intended for use by auditing organizations or as official MDSAP auditor training or as part of the MDSAP assessment criteria.
For More Information about Medical DevicesIf you have any questions about CDRH Learn, or medical devices in general, contact the Division of Industry and Consumer Education (DICE):
- Phone: (800) 638-2041 or 301-796-7100; 9 am - 4:30 pm Eastern Time
- Email: DICE@fda.hhs.gov
Please visit us at our website for more information about how we may help you.
Thank You,
Food and Drug Administration
Center for Device and Radiological Health
Center for Device and Radiological Health
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