Many providers of in vitro diagnostic (IVD) laboratory instruments successfully launch their lab instruments in Europe but are wary of bringing their product to the US market. One concern is the amount of effort required to comply with the regulatory requirements of the Food & Drugs Administration (FDA).
FDA registration categories
FDA registration classifies medical devices, including IVD laboratory instruments, into three categories depending on the risk associated with the product: Class I products bear a low risk (e.g., general laboratory equipment for a specific clinical use); Class II devices are higher risk products (e.g., lab instrumentation for clinical multiplex test systems); and Class III includes products with the highest risk, such as HPV detection systems. The level of regulatory control required increases with increasing risk. However, in many cases, particularly for Class I and specific Class II products, the level of effort required to achieve regulatory compliance is manageable.
FDA registration requirements
A crucial prerequisite for successful FDA registration is an established quality management system complying with the requirements of FDA 21 CFR part 820, also known as “QSR” (Quality System Regulation) or “GMP” (Good Manufacturing Practice). IVD laboratory instruments providers must define and implement adequate processes and develop and manufacture their products based on these GMP requirements to pass the FDA registration. This includes, amongst others, setting up the Design History File (DHF) with design and development planning, clearly defined product requirements, and planned and successfully completed verification and validation activities. Furthermore, the Device Master Record (DMR) with appropriate specifications and procedures for production and testing of the finished IVD laboratory instrument must be compiled and updated in case of changes. And, finally, the Device History Record (DHR) containing the production history of each batch, lot, or unit needs to be defined, completed, and maintained.
Many of the FDA’s QSR requirements are comparable with the provisions of the ISO 13485 standard, the most recent revision of which is more closely aligned with US regulations.
IVD laboratory instruments provider must submit a Premarket Notification for the US market
In addition to the requirements mentioned above, which are audited by the FDA with initial, pre-approval, or regular inspections, companies that want to market IVD Laboratory instruments in the US must submit a Premarket Notification (510(k)) for not exempted Class I or II products or a Premarket Approval (PMA) for Class III products and register the business (establishment registration) and the product (medical device listing) with the FDA.
How far away is the FDA registration of your IVD laboratory instrument?
The FDA registration of your lab instrument is not as far away as you think. Go through this free checklist and consider if your product meets the expectations to pass the FDA registration of your IVD laboratory instrument in the US market successfully.
Posted by Patrick Widler