What are Medical Devices?
Per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
(A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
(B) 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
(C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its 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 its primary intended purposes.
To determine if your product meets the definition of a medical device, you should define the intended use and indications for use of your product. If it does meet the definition of a medical device, next you must determine if an appropriate product classification exists for your device.
FDA classifies medical devices into Class I, Class II, and Class III according to the level of regulatory control that is necessary to reasonably assure safety and effectiveness. Each classification comes with its own set of rules that determine how devices can be marketed and the appropriate premarket process.
Class I medical devices pose minimal potential harm to the patient (low risk) and therefore have the least amount of regulatory control. Most Class I devices do not require a premarket submission and are 510(k) exempt. Instead, they must follow basic guidelines called general controls. Examples of Class I medical devices are: oxygen masks, tongue depressors, bandages, and handheld surgical instruments.
Class II medical devices pose more harm to the patient than Class I devices (moderate risk) and thus require more FDA regulation to assure safety and effectiveness. Class II devices must abide by general controls as well as special controls such as labeling requirements, post-market surveillance, and mandatory performance standards. The FDA requires Class II Devices to be cleared via a 510(k) premarket submission before the device can be marketed in the US. A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent (SE), to a legally marketed device (predicate) [21 CFR 807.92(a)(3)] that is not subject to premarket approval (PMA). Examples of Class II medical devices are: Contact Lenses, Catheters, suture needles, and non-spinal bone screws.
For medical devices with no predicate device the De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls provide reasonable assurance of safety and effectiveness for the intended us. De Novo classification is a risk-based classification process. Through a De Novo Classification Request (De Novo request) devices are classified as either Class I or II and may be marketed and used as predicates for future premarket notification [510(k)] submissions.
Class III medical devices are used to support or sustain human life or those that pose the most harm to the patient (high risk) and are regulated most rigorously by the FDA. Class III medical devices require Premarket approval (PMA) by the FDA before the device can be placed on the market in the US. PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness. A PMA is a much lengthier submission requiring not only data to show substantial equivalence, but information on the manufacturers quality management system. Examples of Class III medical devices are: Defibrillators, Cochlear implants, and Heart valves.
Folio Consulting Group, LLC has experience helping medical device manufacturers successfully complete their premarket submissions and gain access to the US market. Contact us today to help develop your regulatory strategy and file your 510(k), De Novo, or PMA.