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PRE-REVIEW FORM: COMPANY/DEVICE HISTORY Please complete the pre-review form prior to beginning the review of this 510(k). This form is designed to be a tool to identify key items that may be important
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How to fill out pre-review form companydevice history?

01
Start by gathering all relevant information about the companydevice history, such as previous maintenance records, repair reports, and any other relevant documentation.
02
Review the pre-review form carefully to understand the specific information required and the format in which it needs to be provided.
03
Begin filling out the form by entering the company's name, contact information, and any other identification details requested.
04
Proceed to provide detailed information about the device's history, including its make, model, and serial number.
05
Fill in the dates of any previous maintenance or repairs conducted on the device, along with the type of service performed.
06
Include any additional relevant information, such as warranty or insurance details, if applicable.
07
Ensure that all the provided information is accurate and complete, double-checking for any errors or omissions.
08
Submit the filled-out pre-review form according to the designated method, whether it's through email, an online portal, or in person.

Who needs pre-review form companydevice history?

01
Companies or organizations that own or manage devices or equipment with a maintenance history requirement.
02
Service providers or technicians responsible for reviewing and servicing company devices.
03
Regulatory bodies or authorities requiring documentation of the company's device history for compliance or audit purposes.
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The pre-review form companydevice history is a document that provides a detailed record of the reviews conducted before the release of a company device.
All companies that manufacture or distribute devices are required to file the pre-review form companydevice history.
The pre-review form companydevice history can be filled out by providing detailed information about the device, its manufacturing process, quality control measures, and any previous reviews conducted.
The purpose of the pre-review form companydevice history is to ensure the safety and effectiveness of company devices before they are released to the market.
The pre-review form companydevice history must include information about the device's design, components, manufacturing process, quality control procedures, previous reviews, and any reported issues or incidents.
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Related Links

Premarket Approval (PMA)
May 16, 2019 — Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
PMA Review Process
Sep 13, 2021 — The review of a premarket approval application (PMA) is a four-step review process consisting of: Filing a PMA (21 CFR. 814.42)
PMA Application Contents
Apr 22, 2024 — All PMA applications must include a completed copy of form FDA-3674. See Form FDA-3674, ClinicalTrials.gov Data Bank for additional information.

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