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The FDA considers a product to be a device, and subject to FDA regulation, if it meets the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act.
Section 201(h) of the Food, Drug & Cosmetic Act (FD&C Act) defines a device as: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other...
Explain FDA’s role in regulating medical devices. Define a medical device and review basics about device classification. Describe five steps to get a new product to market. Identify different...
A device is in class II if general controls alone are insufficient to provide reasonable assurance of its safety and effectiveness and there is sufficient information to establish special controls, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (includ...
(r) Product means components, manufacturing materials, in- process devices, finished devices, and returned devices. ( s ) Quality means the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.
Exemptions from Federal Preemption of State and Local Medical Device Requirements: 808.1 – 808.101
For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 820.1 - Scope. § 820.3 - Definitions. § 820.5 - Quality system. § 820.20 - Management responsibility. § 820.22 - Quality audit. § 820.25 - Personnel. § 820.30 - Design controls. § 820.40 - Document controls.
What is a medical device? The FDA regulations define items that are considered medical devices. A medical device is defined, in part, as any health care product that does not achieve its primary intended purposes by chemical action or by being metabolized.
What is an FDA Class III medical device? The FDA defines Class III devices as products which: “usually sustain or support life, are implanted or present a potential unreasonable risk of illness or injury."
FDA’s determination of whether to classify a product as a drug or device is based on statutory definitions, as set forth in sections 201(g) and 201(h) of the FD&C Act, respectively.