Does Your Invention Fit the Concept of a Medical Device? 

Meet John. One day, while John was getting his 6-month-old ready for daycare, he noticed his baby felt a little warm to the touch. Unfortunately, with no thermometer in sight, he couldn’t confirm whether his son did in fact have an elevated temperature, or possibly even a fever. He thought to himself, “Why don’t they make pacifiers and baby bottles with thermometers attached for dads like me?” 

A lightbulb went off in John’s head—this idea might actually be the springboard to a much-needed invention benefitting parents worldwide. 

Not so fast, John! Assuming this type of medical device does not already exist, you first need to determine whether the FDA would even approve bringing it to market. 

One potential option is to prepare a 510(k) submission. It is typically the shortest pathway to FDA clearance because the proving grounds for safety and efficacy are based on a predicate device (i.e., an existing product similar in design and intended use) that may be legally marketed in the U.S. (Please note: The FDA determines if a product concept meets U.S. legal and industry requirements to be considered a medical device.) 

While the above scenario is fictitious, our team at Pathway NPI meets with both novice and experienced medical device companies and inventors all the time to discuss whether their concepts are viable. We work to educate our clients on all of their options, including the proper classifications for their medical devices and the best regulatory pathways to gain FDA approval.

Below we discuss the nature and potential applications of medical devices, to help you understand if your product concept fits these criteria. 

What Exactly Is a Medical Device?

Briefly, let’s define what a medical device is. According to the FDA, a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article” used to diagnose, treat, or cure medical conditions. 

Medical devices are ranked based on their level of possible risk to the public. The classifications are Class I, II, and III, as set forth by the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act. The lower the class, the lower the risk. Inversely, the higher the class, the greater the risk to consumers. 

Class I medical devices are generally thought to be safe and do not pose significant health risks (think Band-Aids and adult diapers). Class II medical devices pose a low-to-moderate risk to the general public, and may include items like powered wheelchairs and pregnancy tests. Class III medical devices tend to be riskier or more invasive—dialysis catheters and pacemakers for the heart are prime examples. The FDA lists other examples and information here

How Do You Determine the Class of a Medical Device?

Determining if your device concept would be suitable to diagnose, treat, or cure a medical condition is not so cut and dry. However, if a product on the market has similar intended use and design components, the determination is more seamless. A 510(k) submission approval shows that there’s a predicate or substantially equivalent medical device product on the market. Also, the predicate device must be safe and effective for public use. Class I medical devices usually fall under this category.

If your medical device appears to fit 510(k) premarket submission criteria, here are some steps that Pathway NPI will take to guarantee a seamless process:

  • We help you determine the appropriate classification for your proposed medical device by thoroughly evaluating its intended use.
  • We confirm our hypothesis about classification by consulting the FDA’s database in pursuit of predicate medical devices. We also search for a three-letter product code and regulation number for your medical device.
  • Our company offers a comprehensive suite of design, development, and manufacturing services, which enables us to identify and address any potential issues with a medical device quickly and seamlessly. If we discover flaws in a product design, for instance, we might recommend enhancements or a complete concept overhaul. 
  • We gather information (surveys, clinical studies, etc.) and all necessary documentation to proceed with the 510(k) process.
  • If the FDA approves your application, information about your medical device and its 510(k) designation will be posted on the FDA website.

Getting a 510(k) designation doesn’t mean your medical device is fully approved for market launch; rather, it means that it’s FDA-cleared. After receiving FDA clearance, the results of further research and testing will need to be reviewed by the FDA.

Remember, the FDA is a consumer protection agency that monitors the activities of various industries such as medical device manufacturing, pharmaceutical, and food service. Its No. 1 priority is to place products on the market that have limited risk and do not adversely affect the quality of life of the public. The guidance that Pathway NPI gives its clients might include changing the labeling on their medical devices or outsourcing their manufacturing needs. These types of scenarios require additional 510(k) submission processes so that the FDA can determine if significant changes have been made to the original intended use and safety of the medical device. 

Let the regulatory experts at Pathway NPI assist with your medical device launch. Contact us today for a free consultation.