Scott Gottlieb, who served as 23rd Commissioner of Food and Drug Administration (FDA) is very well known for accurately prognosticating the future of the Medical Device Industry. In one of his articles written for ‘The New Atlantis’ in the year 2003, Scott had rightly anticipated that the marriage of biology and silicon is going to significantly transform the medicine industry. This was during the times when people believed that the future of medicines was going to lie in embryo research, tissue transplants, or stem cells. Scott had differed these claims right there in 2003 stating that the future of medicine is going to lie in DNA chips, supercomputers, and new drugs instead. Today, if we take a look at the top 10 emerging technologies in the year 2020, it becomes absolutely impossible to disagree with Scott’s vision back then.
Fast forward in 2020, given the rapid evolution of the Medical Device industry, Dr. Stephen M. Hahn, who joined as 24th Commissioner of the FDA has maintained his focus on upholding the gold standard for medical products. He is supporting the development of a surveillance program to track how well medical devices do after they've hit the market. Under his leadership FDA has already banned the use of electrical stimulation devices for self-injurious or aggressive behaviour.
Stephen M. Hahn
This means that in coming years it would be appropriate to anticipate FDA to work aggressively on stringent regulatory requirements for usage and approval of medical devices as well as their post marketing surveillance. In the context of the healthcare industry it becomes needless to say that ‘Patient Safety’ is the prime focus and that is why FDA proposes risk based classification of Medical devices into Class I, II and III. Class I includes devices with the lowest risk and Class III includes those with the greatest risk.The risk is anticipated based on invasiveness of the medical device and its impact on the overall health of the patient which is determined by intended use as well as indications for use of the device.
The FDA has classified around 1,700 different generic types of devices, which are in turn grouped into 16 medical panels as defined by 21 CFR 862 to 21 CFR 892. These are then assigned to one of the three regulatory classes to determine the level of control necessary to assure the safety and effectiveness of the device.
Class I Medical Devices
Class I medical devices are those devices that have a low to moderate risk to the patient and/or user. Given the low risk involved these devices are only required to meet general controls. This is the reason why 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process. If a device falls into a generic category of exempted Class I devices, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, the manufacturer is required to register their establishment and list their generic product with FDA. Examples include wheelchairs, elastic bandages, manual stethoscopes, and bedpans.
Class II Medical Devices
Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. These are the devices which require general as well as special controls.Today, 43% of medical devices fall under this category. Most of the medical devices fall in the category of Class II devices. Examples of Class II devices include catheters, needles and contact lenses.
Class III Medical Devices
Class III medical devices are those devices that have a high risk to the patient and/or user. Owing to the high risk involved, these devices need to meet general controls and obtain pre-market approval. These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. They represent 10% of medical devices regulated by the FDA. Examples of Class III devices include implantable pacemakers, coronary stents, orthopedic implants and breast implants.
How to know the Class of your Device?
FDA provides excellent resources for device classification which can be used effectively for device classification. The device classification can be performed in following ways:
- Search for an appropriate product classification in FDA database. This is the most common method.
- Search for a similar device by surfing 501(k) Clearance Database, Pre-market Approval Database and De Novo Database.
- Search for a similar device by surfing Establishment Registration and Device Listing Database.
What are Different Levels of Controls for Medical Devices?
The examples of general controls which the Class I, II and III Medical Devices need to meet are as below:
(21 CFR Part)
|Adulterated||FD&CA 501||Provide device not proper for use|
|Misbranded||FD&CA 502||Provide false or misleading labeling|
|Labeling||801||Provide information for users|
|Medical Device Reporting||803||Report device-related injuries and deaths|
|Establishment Registration||807||Register company with FDA|
|Device Listing||807||Identify devices with FDA|
|807||Substantially equivalent to legally marketed device|
|Quality System/Good Manu. Practices||820||Ensure safe and effective finished devices|
These are applicable to class II devices:
- Special Labeling
- Design Characteristics or Specifications
- Performance Standards
- Premarket Data Requirements
- Guidance Documents
This is typically a requisite for life supporting and life sustaining Class III devices. As the General and Special Controls are insufficient to provide reasonable assurance of safety and effectiveness.
Given the high risk potential of Class III Medical Devices they are required to meet very stringent standards of safety and efficacy as compared to Class I and Class II devices.Therefore most of them need to undergo Premarket Notification 510(k) and Premarket Approval to prove substantial equivalence as per 21 CFR 814. Most of the Class I and Class II devices are exempt from this process allowing for the faster entry into the US market.
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