Which section of 21 CFR 820 describes process validation?

820.75
21 CFR 820.75 – Process validation.

Do GMPS apply to medical devices?

GMP Exemptions FDA has determined that certain types of medical devices are exempt from GMP requirements. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180).

Which subpart of 21 CFR Part 820 explains about design control?

21 CFR Part 820 Subpart C—Design controls What it covers: 21 CFR Part 820 Subpart C covers design controls. Design controls are procedures that ensure devices are designed according to their requirements.

Is ISO 13485 required for FDA?

ISO 13485:2016 is not a regulation or law, however, while FDA 21 CFR Part 820 is mandatory for medical device distribution in the United States. Historically, just because a medical device company was certified to ISO 13485:2016 had little to no baring with respect to compliance with Part 820 in the eyes of FDA.

What is mean by 21 CFR Part?

The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.. Title 21 of the CFR is reserved for rules of the Food and Drug Administration. Each title (or volume) of the CFR is revised once each calendar year.

What is CFR 21?

21 CFR is a title within the Code of Federal Regulations. Title 21 is reserved for the rules of the United States Food and Drug Administration (FDA).

What does Title 21 mean?

Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). It is divided into three chapters: Chapter I — Food and Drug Administration.

What does code of Federal Regulations mean?

in: Code of Federal Regulations. The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations (sometimes called administrative law) published in the Federal Register by the executive departments and agencies of the Federal Government of the United States.