Get the free MDUFA Performance Goals and Procedures - fda

This document outlines the performance goals and procedures agreed upon by the FDA for the medical device user fee program as part of the Medical Device User Fee Amendments of 2012, detailing the

How to fill out mdufa performance goals and

How to fill out MDUFA Performance Goals and Procedures

1. Review the MDUFA Performance Goals document to understand the requirements.
2. Identify the key sections that require input for the goals and procedures.
3. Gather relevant data and metrics from previous performance evaluations.
4. Collaborate with stakeholders to discuss goals and potential procedures.
5. Draft the performance goals and detail the associated procedures.
6. Ensure that the goals are specific, measurable, achievable, relevant, and time-bound (SMART).
7. Submit the draft for review by legal and compliance teams.
8. Revise the document based on feedback received.
9. Finalize the MDUFA Performance Goals and Procedures document.
10. Distribute the final version to all relevant parties for implementation.

Who needs MDUFA Performance Goals and Procedures?

1. The FDA regulators involved in the medical device review process.
2. Medical device manufacturers looking to understand performance expectations.
3. Stakeholders needing to align with MDUFA guidelines.
4. Policy makers interested in ensuring efficient industry and regulatory interactions.

People Also Ask about

Does the FDA charge for Q submission fees?

What is the FDA Q-submission fee? The FDA does not charge any fee for any Q-submission meeting.

What is the difference between Pdufa and Gdufa?

GDUFA and PDUFA are US FDA programs that are designed to help the agency hire and retain a sufficient number and types of technical and scientific experts to evaluate human drug applications (NDAs and ANDAs) efficiently and predictably. GDUFA is associated with ANDAs, whereas PDUFA is associated with NDAs.

What is the purpose of the user fee?

A user fee is a charge imposed by the government for the primary purpose of covering the cost of providing a service, directly raising funds from the people who benefit from the particular public good or service being provided.

What is the FDA medical device safety Action Plan?

The FDA's Medical Device Safety Action Plan outlines a vision for how the FDA can continue to enhance its programs and processes to assure the safety of medical devices throughout their life cycle, to provide for the timely communication and resolution of safety issues, and to advance innovative technologies that are

What is Mdufa in FDA?

Medical Device User Fee and Modernization Act. The Medical Device User Fee and Modernization Act (MDUFA) authorizes the Center for Devices and Radiological Health (CDRH) to collect user fees from medical device manufacturers. It is reauthorized every 5 years.

For pdfFiller’s FAQs

What is MDUFA Performance Goals and Procedures?

MDUFA Performance Goals and Procedures refer to the framework established under the Medical Device User Fee Amendments (MDUFA) that outlines performance goals for the review of medical device applications, including timelines for reviews and actions taken by the FDA.

Who is required to file MDUFA Performance Goals and Procedures?

Entities that submit medical device applications to the FDA are required to adhere to MDUFA Performance Goals and Procedures. This typically includes medical device manufacturers and sponsors.

How to fill out MDUFA Performance Goals and Procedures?

To fill out MDUFA Performance Goals and Procedures, applicants must complete the relevant forms provided by the FDA, ensuring that all required information, including performance metrics and timelines, is accurately provided and submitted along with their application.

What is the purpose of MDUFA Performance Goals and Procedures?

The purpose of MDUFA Performance Goals and Procedures is to enhance the efficiency and effectiveness of the FDA’s medical device review process, ensuring timely evaluations of device submissions while maintaining high standards for safety and effectiveness.

What information must be reported on MDUFA Performance Goals and Procedures?

MDUFA Performance Goals and Procedures require reporting information such as submission dates, review timelines, outcomes of reviews, and any delays encountered during the review process, along with the reasons for such delays.