According to Gartner Market Insights, the healthcare IT market is expected to be worth an enormous US$441.8 bn by 2025. The innovation of technology and increased applications and disruptive devices entering the market can make it a little difficult to distinguish which products should be considered medical devices and which should not All companies who plan to sell a medical device or in vitro diagnostic (IVD) in the United States are required to register their product with the United States Food and Drug Administration (FDA). It is vital to determine the classification of the medical device or IVD as each classification has different regulations and requirements for registration and certification procedures.
The first step is to determine the classification of the medical device or IVD. This can be done by searching the FDA classification database or by identifying another device with the same intended use and technology.
Some Class I devices are exempt from most Quality System Regulation (QSR) requirements, with exceptions. For Class II and III devices, businesses should implement Quality Management Systems (QMS) that meet the FDA QSR found in 21 CFR Part 820.
Most Class I devices can be self-registered, but most Class II devices require a 510(k) submission. This involves a very in-depth submission essentially validating that the device falls within the spectrum of safety, usability, and intended use requirements that are set out by the FDA. 510(k) submissions are often completed by verified organisations who specialise in this area, as approximately 69% of submissions are rejected the first time.
For Class III devices, a Pre-Market (PMA) submission is required. This may involve the requirement to undergo clinical studies and trials and will need to receive feedback from the FDA. If clinical studies are required, businesses should apply for an Investigational Device Exemption (IDE). The business should develop a protocol for the trial/s and conduct the study. All Class III devices also require facility inspections from the FDA for all major suppliers and the manufacturer involved in the production of the device. All involved parties must be compliant with FDA QSR.
The device manufacturer will then receive either a 510(k) clearance letter (for Class II) or a PMA approval letter (for Class III) from the FDA. At this time, businesses must be fully compliant with the required QSR. It’s important to bear in mind that even though the FDA may not inspect Class I or II device manufacturers prior to device registration, they may conduct random inspections after and can issue a ‘Form 483’ for non-compliance if the device does not meet the required standards.
If the business does not have a local presence in the USA, an FDA US Agent representative must be appointed as a local point of contact. The device must also be listed and the company registered using FURLS system on the FDA website. Fees must be paid for Establishment Registration and Listing, which must be renewed each year.
Once these steps are carried out, the device is ready to sell in the USA. Businesses may opt to carry out what are known as ‘Voluntary Consensus Standards’ on their products, which are essentially documents that have been approved by a recognised body for common and repeated use, rules, guidelines, or characteristics for activities or their results. A voluntary consensus standard is one that is developed or adopted by Standards Development Organisations (SDOs), both domestically and internationally, according to strict consensus principles. Opting for such approval or certification can assist with the procedure of having the device registered with the FDA and essentially being able to sell the device in the USA.