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This document provides guidance on the FDA's requirements for the premarketing review and approval of immunohistochemistry devices, outlining necessary documentation, safety, and performance standards.

How to fill out guidance for submission of

How to fill out Guidance for Submission of Immunohistochemistry Applications to the FDA

1. Obtain the Guidance for Submission of Immunohistochemistry Applications document from the FDA website.
2. Review the document thoroughly to understand the requirements and expectations.
3. Gather all necessary materials and data related to your immunohistochemistry application.
4. Follow the specific formatting and submission guidelines outlined in the document.
5. Complete the application form, ensuring all sections are filled out accurately.
6. Include all required supporting documents and data sets.
7. Double-check for any missing information or documents before final submission.
8. Submit your application electronically through the FDA's designated submission portal.

Who needs Guidance for Submission of Immunohistochemistry Applications to the FDA?

1. Researchers and developers of immunohistochemistry assays seeking FDA approval.
2. Pharmaceutical companies involved in the development of diagnostic tests.
3. Clinical laboratories offering immunohistochemistry testing services.
4. Regulatory affairs professionals ensuring compliance with FDA regulations.

People Also Ask about

What is the procedure of immunohistochemistry?

The sequential steps in IHC can be summarized as follows: antigen retrieval (AR), addition of primary antibody, application of a secondary antibody that binds the primary antibody, and addition of a detection reagent to localize the primary antibody (Fig 1).

What is IHC sensitivity and specificity?

IHC assays are often defined by their sensitivity and specificity. Analytical sensitivity refers to the lower limit of detection of an assay or the minimal amount of protein that can be detected, while analytical specificity refers to the degree to which the antibody only binds the protein of interest.

How do I report something to the FDA?

If you are not able to use the SmartHub, you may also call 1-888-INFO-FDA and follow the prompts to report a problem.

How do I submit an application to the FDA?

In order to submit a complete ANDA, applicants should review the following forms and prepare all that are required for your specific application. Filing Review of ANDAs MAPP including filing checklist (PDF - 521 KB) Form FDA-356h: Application to Market a New Drug, Biologic, or Antibiotic Drug for Human Use (PDF - 2 MB)

What documentation is required for FDA?

What documents should I provide to FDA? You should provide FDA with entry documentation which may include the following: Bill of Lading (BOL), Airway Bill (AWB), invoice, and purchase order.

How do I submit documents to FDA?

How to submit to the FDA Mail to CDER (Currently not being accepted by CDER): Mail application in triplicates (one original and two copies) or an e-copy (CD, flash drive, etc.) Submit through CDER NextGen Portal. FDA Electronic Submissions Gateway (please see below on instructions how to use)

What is the protocol for immunohistochemistry staining for stained tissue?

The steps of the immunohistochemistry protocol include fix, section and mount, deparaffinization and antigen retrieval, block, applying antibodies, and applying substrate. The tissue sample is fixed by applying a fixative which maintains the structure of the sample and prevents decomposition.

How do I submit documents to the FDA?

You need to use FDA's eSubmitter software: Save your text documents as . Download and eSubmitter, if you have not already done so. Open eSubmitter. Click "create new submission." Select the eSubmitter template for the submission type you want to create: Follow the guided process within eSubmitter.

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What is Guidance for Submission of Immunohistochemistry Applications to the FDA?

The Guidance for Submission of Immunohistochemistry Applications to the FDA provides recommendations and requirements for the development and regulatory submission of immunohistochemistry (IHC) assays intended for use in the diagnostic setting.

Who is required to file Guidance for Submission of Immunohistochemistry Applications to the FDA?

Entities such as diagnostic device manufacturers, sponsors, and developers of IHC assays intending to obtain FDA approval or clearance for their products are required to file under this guidance.

How to fill out Guidance for Submission of Immunohistochemistry Applications to the FDA?

To fill out the guidance, applicants should follow the outlined sections in the document which include detailed instructions on study design, validation, performance characteristics, labeling, and post-market surveillance as required by the FDA.

What is the purpose of Guidance for Submission of Immunohistochemistry Applications to the FDA?

The purpose of the guidance is to provide a clear framework for manufacturers on the expectations and requirements for IHC assays to ensure safety, effectiveness, and regulatory compliance.

What information must be reported on Guidance for Submission of Immunohistochemistry Applications to the FDA?

Information that must be reported includes the assay’s analytical performance, clinical performance data, intended use, labeling information, and any risk assessments associated with the use of the IHC assay.