What is 21 CFR Subchapter J?
What is 21 CFR Subchapter J?
As used in this subchapter J: (a) Accidental radiation occurrence means a single event or series of events that has/have resulted in injurious or potentially injurious exposure of any person to electronic product radiation as a result of the manufacturing, testing, or use of an electronic product.
What does CFR 21 cover?
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).
What is 21 CFR laser?
Through 21 CFR 1040, the US Food and Drug Administration (FDA) regulates laser products entering commerce and requires all class IIIb and class IV lasers offered in commerce in the US to have five standard safety features: a key switch, a safety interlock dongle, a power indicator, an aperture shutter, and an emission …
What is 21st CFR?
Title 21 of the CFR or the Code of Federal Regulations deals with governing of food and drugs in the United States for three of its governing bodies: The FDA (Food and Drug Administration), DEA (Drug Enforcement Agency) and ONDCP (Office of National Drug Control Policy).
Which parts of 21 CFR deal with drugs?
21 CFR Chapter I – FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER A – GENERAL (Parts 1 – 99)
- SUBCHAPTER B – FOOD FOR HUMAN CONSUMPTION (Parts 100 – 191-199)
- SUBCHAPTER C – DRUGS: GENERAL (Parts 200 – 299)
- SUBCHAPTER D – DRUGS FOR HUMAN USE (Parts 300 – 370-499)
Who does 21 CFR part 11 apply to?
Practically speaking, Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions.
What is the difference between CFR and eCFR?
The Code of Federal Regulations (CFR) is current with the published print version of the CFR. As an alternative resource, the Electronic Code of Federal Regulations (eCFR), is a currently updated version of the CFR. It is not an official legal edition of the CFR.
What is the most powerful type of laser?
A team of researchers from Osaka University recently fired the most powerful laser on the planet: a 2 petawatt pulse, that’s 2 quadrillion watts, albeit for just one trillionth of a second. It’s called the LFEX (Laser for Fast Ignition Experiments) and it measures more than 300 feet in length.
What is 21 CFR Part 820 and why should you care?
What is 21 CFR Part 820 and why should you care? 21 CFR Part 820 is part of the Current Good Manufacturing Practice (CGMP) regulations. It ensures that all medical devices created and developed within the US market are safe and follow satisfactory quality processes at all stages of development.
How do you reference 21 CFR?
Type the title number of the regulation, then the abbreviation “C.F.R.” Type a space, then type the section symbol (§), a space, and the number of the section. Close your reference with the edition year of the CFR. Type a space after the section number, then type the year of the CFR edition in parentheses.
Who must comply with 21 CFR Part 11?
What Is 21 CFR Part 11? 21 CFR Part 11 states that electronic records and electronic signatures are treated the same as paper records and handwritten signatures. Regulated companies with any documents or records in electronic format must comply with the regulation.