22.3.1 Medical Device Definition
A medical device is defined16 within the Food Drug & Cosmetic Act as “… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it’s primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
Medical devices distributed in the United Sates are subject to General Controls, premarketing and post marketing regulatory controls.
General Controls include:
1. Establishment Registration by manufacturers, distributors, repackages and relabelers,
2. Medical Device Listing with FDA of devices to be marketed,
3. Manufacturing the devices in accordance with Good Manufacturing Practices,
4. Labeling medical devices in accordance with the labeling regulations,
21 CFR §801 & §809,
5. Medical Device Reporting of adverse events as identified by the user, manufacturer and/or distributor of the medial device.
Premarketing (a. k.a. Special) controls are device – and device-classification specific. Premarketing controls for a medical device may include: clearance to market by 510(k) or approval to market by PreMarket Approval (PMA).
Postmarketing controls include Device Listing, Medical Device Reporting (MDR), Establishment Registration, and Quality System Compliance Inspection.