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This document outlines the FDA's program for accrediting third parties to conduct inspections of manufacturers of class II or III medical devices under the Medical Device User Fee and Modernization

How to fill out inspection by accredited persons

How to fill out Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002

1. Review the requirements of the Inspection by Accredited Persons Program outlined in the Medical Device User Fee and Modernization Act of 2002.
2. Ensure your facility meets the eligibility criteria for participation in the program.
3. Identify an accredited organization that can conduct the inspection.
4. Prepare for the inspection by ensuring all relevant documentation and records are organized and accessible.
5. Schedule the inspection with the accredited organization.
6. Conduct a pre-inspection meeting with the inspection team to clarify the process and expectations.
7. Participate in the inspection, addressing any questions or concerns raised by the inspectors.
8. After the inspection, review the findings and recommendations provided by the inspection team.
9. Implement any necessary corrective actions based on the inspection results.
10. Maintain records of the inspection and any follow-up actions taken.

Who needs Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002?

1. Manufacturers of medical devices who wish to participate in the Inspection by Accredited Persons Program.
2. Medical device firms looking to streamline their inspection processes under FDA regulations.
3. Businesses aiming to gain compliance with the Medical Device User Fee and Modernization Act of 2002.

People Also Ask about

What are the 3 main types of inspections?

There are 3 inspection task types: preventive control inspections, sample collection, and commodity inspections. Preventive control inspection. Sample collection. Commodity inspection. The inspection process. 3.1 Determine the scope of the inspection. 3.2 Establish the team. 3.3 Review information.

What is the Medical Device User fee and Modernization Act 2002?

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L 107-250, amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide FDA new responsibilities, resources, and challenges. MDUFMA was signed into law October 26, 2002.

What are the 4 types of FDA inspections?

The four different types of FDA inspections are pre-approval inspection, routine inspection, compliance follow-up inspection, and “for cause” inspection. Each is intended to help protect the public from unsafe products, but the focus and expectations of each type of inspection are different.

What is Section 206 of the medical device User Charge and Modernization Act Mdufma?

(Sec. 206) Allows labeling for prescription devices intended for use in health care facilities to be made available solely by electronic means, provided that a manufacturer furnishes a paper copy for free upon request by a health care facility.

What are the different types of FDA inspections?

There are Four Types of FDA Inspections, but They Don't Apply to Everyone. There are four types of FDA inspections for medical device manufacturers: pre-approval inspections, routine inspections, follow-up inspections, and for cause inspections.

What are the 4 types of quality inspection?

In quality control, there are 4 types of quality inspections, namely: Pre-Production Inspection, During Production Inspection, Pre-Shipment Inspection, and Container Loading/Unloading Inspections. Each of these types of inspection has its own purpose.

What are the 4 types of FDA enforcement actions?

Enforcement Actions (CBER) Warning Letters. Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letters. Untitled Letters. Administrative License Action Letters.

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What is Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002?

The Inspection by Accredited Persons Program is a framework established under the Medical Device User Fee and Modernization Act of 2002 that allows certain accredited organizations to conduct inspections of medical device manufacturers on behalf of the FDA, thereby streamlining the regulatory process.

Who is required to file Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002?

Medical device manufacturers who are subject to premarket approval and those seeking to comply with FDA inspection requirements are required to participate in the Inspection by Accredited Persons Program.

How to fill out Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002?

To fill out the necessary documentation for the Inspection by Accredited Persons Program, manufacturers must provide detailed information about their facility, the devices being manufactured, and evidence of compliance with relevant standards, as specified by the accredited organization.

What is the purpose of Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002?

The purpose of the Inspection by Accredited Persons Program is to enhance the efficiency and effectiveness of the medical device regulatory process by utilizing accredited third-party organizations to conduct inspections, thus reducing the burden on FDA resources.

What information must be reported on Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002?

Manufacturers must report inspection outcomes, compliance statuses, any non-conformities identified during the inspection, and corrective actions taken. This information is critical for maintaining quality and safety standards in medical device manufacturing.