Medical Devices – An Introduction to Marketing and Classifications

If you have been thinking of starting a medical device company but are overwhelmed by the sheer amount of FDA regulations, the process of obtaining a patient, and the nuances of marketing, then you have come to the right place.

If you already know about the process of filing and obtaining a patent, and the intricacies of clinical trials, you must be thinking about the process of marketing your invention. Sure enough, there are rules set forth by the FDA regulating the marketing of such products. For this post, I will provide an overview of medical device classifications, and what needs to be done based on those classifications prior to marketing a medical device.

The regulatory aspect of all things pertaining to medical devices can be found in Title 21 Code of Federal Regulations Parts 862-892. There are 16 medical categories in which a device may fall into.

Medical device categories under 21 C.F.R. Pt. 862-892. Source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H

 

Classifications

Often, new companies assume they must file a premarket approval application (PMA) before marketing their device. However, this is only true if the device is completely novel, is a novel take on an existing device or if it is a class III device. Devices are divided into three classes based on their function and invasiveness. These three classes determine how subsequent marketing can be carried out. The statutory language regarding medical device classification can be found in Title 21 C.F.R. § 860.3. Most devices created only need to file a 501(K) with the FDA.

 

501(K) Form

The 501(K) form is a notice provided to the FDA and must be filed at least 90 days before you plan to market your device. Generally, the form will be processed within 30-90 days by the FDA. On the 501(K) forms, the most important aspect is showing that your device is virtually the same or substantially equivalent to an existing device that has significant data on its use. Often, this is where 501(K) submissions fall short. It is critical to explain in depth as to why your device is not novel and is essentially the same as an existing device. On the 501(K), you do not need to show any human clinical trial data, laboratory data is sufficient if you can prove that your device is not novel.

 

Class I

A Class I medical device is one which is developed subject to the FDA general controls guidelines and has minimal risk of harm. Meaning, it follows basic FDA protocol in terms of development, branding and labeling, registration, and use. General control products do not require post market surveillance (data collected when a device is public after clinical trials). If your device falls under Class I or has some exceptions but shows no chance of bodily impairment and is not used as a life-sustaining device, you only need to file a 501(K) before marketing.

 

Class I Exempt Devices

Class I exempt devices are those which need to go through minimal testing and require minimal data. These “devices” are the most basic found in a healthcare setting, with virtually no risk to human health. Such devices include, but are not limited to stethoscopes, self-adherent wraps, and IV tubes. Such devices do not need FDA approval for marketing but do still need to be filed with the FDA.

 

Class II

A Class II medical device is one that is developed in accordance with general controls but also utilizes some special controls. This is because Class II devices are often more invasive than Class I devices and require more testing beyond the general controls set forth by the FDA. In terms of filing, the procedure is the same as a Class I device, however, you must implement some form of post market surveillance, patient registries, or other special controls relevant to the device set forth by the FDA.

 

Class III

Class III medical devices undergo the most rigorous review prior to marketing. Class III devices are those which are life sustaining or have a high risk of impairment to human health. Examples of Class III devices include, but are not limited to pacemakers, ventilators and coronary stents.

Class III devices require a PMA to be filed with the FDA prior to marketing. A PMA requires highly specialized trials and testing beyond what is supplied by the FDA in the general controls and special controls. In order to be approved for marketing, your PMA must include extensive laboratory and clinical data on the device proposed and must compile a list of all patients involved and any adverse events. Furthermore, there must be post market surveillance on the device and any adverse events must be reported to the FDA.

 

Determining Classification

There are two methods that can be utilized to determine what class your created medical device falls under. I would recommend utilizing both to ensure correct classification and to avoid any marketing delays. The first is utilizing the list of medical device categories above and seeing which medical specialty your device falls under. The second is to compare your device to existing and approved medical devices in the FDA Product Classification Database. The Product Classification Database can easily be searched using keywords for various devices.

Database search for an oxygen mask provides which medical specialty it falls under, the classification of the device, and the filing required (or not required in this case). Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=49

 

Conclusion

Once you are confident in your device classification and you have filed the relevant forms with the FDA you can finally move towards marketing. Ensure that you do not mislead consumers with your product. The FDA has very strict rules on labeling and misbranding. If you remain transparent, and do not try to hide anything about the product, you may market it as you wish. Remember, informed consent also applies to medical companies. A consumer has the right to know what they are purchasing for their health.

 

Sources:

1. Header Picture: https://www.tuvsud.com/en-us/industries/healthcare-and-medical-devices
2. https://www.fdli.org/2017/08/prescription-drug-advertising-promotion-regulations-enforcement-select-global-markets/
3. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device
4. https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
5. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=49
6. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H
7. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-800
8. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801
9. https://www.fda.gov/vaccines-blood-biologics/biologics-post-market-activities/postmarketing-clinical-trials
10. https://www.fda.gov/media/71717/download
11. https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances
12. https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls
13. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=814&showFR=1&subpartNode=21:8.0.1.1.11.2
14. https://www.fda.gov/medical-devices/consumers-medical-devices/learn-if-medical-device-has-been-cleared-fda-marketing