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Accordance with requirements of 21 CFR Part 807 - accessdata fda

Accordance with requirements of 21 CFR Part 807 - accessdata fda 2025

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The document is a 510(k) summary for the Blood Pressure Monitor with Stethoscope, Model HBPK-A, submitted by Hangzhou Reli-On Co., Ltd. It outlines the device's compliance with safety and effectiveness standards as per FDA regulations. The device is classified as a Class II blood pressure cuff and is intended for non-invasive measurement of arterial blood pressure in adults. The summary includes details about the company, device specifications, predicate devices, technical characteristics, safety data, and concludes that the device is safe and effective for its intended use.

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What makes a signature 21 CFR Part 11 compliant?

21 CFR Part 11 serves as a framework ensuring the integrity, security, and traceability of electronic records in regulated industries. This regulation permits modernization in the regulated industries by enabling streamlined, secure, and efficient data management.

What are the requirements for 21 CFR Part 11?

Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA. All establishment registrations must be submitted electronically unless a waiver has been granted by FDA.

Do medical device distributors need to register with FDA?

21 CFR Part 820 is the FDA Current Good Manufacturing Practice (CGMP) regulation which became effective on December 18, 1978. The regulations ensure that medical devices distributed in the US market are designed and developed with adequate procedures, people are trained, and quality records are maintained.

What is 21 CFR Part 807 FDA?

Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807).

What are the requirements of 21 CFR Part 11?

In order to be compliant electronic signatures must include: The printed name of the signer. The date and time the signature was executed. A unique user ID.