IVD
Bringing an IVD to the US market means working with two regulators: the FDA for commercial test kits (via 510(k), De Novo or PMA, with CLIA waiver categorisation for point-of-care use) and CMS, which oversees laboratories under CLIA. Laboratory-developed tests currently sit under CLIA oversight following the 2025 court ruling that vacated the FDA's LDT rule.
At Taylored Consultancy Ltd, we make IVD compliance clear and stress-free. We help you choose the right pathway, build your performance evidence, and meet FDA requirements without unnecessary delays.
Clearing the path to market -
regulatory and quality expertise that gets your diagnostics compliant, reliable, and ready for market.
We help you determine the right route - 510(k), De Novo or PMA - and prepare your submission.
For point-of-care and home-use tests, we help you pursue CLIA waiver categorisation.
We help you design and document analytical and clinical performance studies, aligned with CLSI guidelines.
We build your risk management file to the recognised standard.
We review your labelling and instructions for use against FDA requirements, including UDI.
We handle FDA registration and listing, and help foreign manufacturers appoint a US Agent.
For laboratory-developed tests, we help you understand the current CLIA-based position and keep you ready for any future change.
We help you implement a QMS that meets the FDA QMSR and ISO 13485.
We help you evidence usability and human-factors work to show your IVD is safe to use.
Regulations can feel like a headache, but they don't have to be. We make sure you're covered, compliant, and ready to sell - without unnecessary delays or legal pitfalls.
ISO 13485 - Medical devices QMS
ISO 14971 - Risk management for medical devices
ISO 15189 - Medical laboratories quality and competence
ISO 15197 - Blood glucose monitoring systems
ISO 18113 - IVD labelling and instructions for use
ISO 23640 - Stability evaluation of IVD reagents
CLSI guidelines - Laboratory method validation
IEC 61326 - EMC requirements for laboratory equipment
ISO 9001 - General quality management
IEC 62366 - Usability Engineering
It depends on your device's risk class and whether there's a predicate device already on the market: most moderate-risk IVDs go through 510(k) by demonstrating substantial equivalence, while novel or high-risk devices without a predicate may need De Novo or full PMA. Picking the right pathway early avoids wasted submission work down the line.
A CLIA waiver allows a test to be used in simpler settings, like a doctor's office or at home, without the higher oversight required of complex clinical laboratory testing, a common goal for point-of-care and home-use IVDs. Waiver status generally needs to be demonstrated through specific studies alongside your FDA clearance. We help build the case for waiver categorisation as part of your submission strategy.
It's currently unsettled. A 2025 court ruling vacated the FDA's rule that would have brought LDTs under its premarket oversight, so LDTs currently sit under CLIA regulation via CMS rather than FDA. This is an evolving area, so if you run or plan to run LDTs, it's worth getting current guidance rather than relying on outdated assumptions.
Yes, foreign IVD manufacturers need a US Agent to act as a point of contact with the FDA, alongside establishment registration and device listing. We provide US Agent support so overseas manufacturers have that presence covered without opening a US office.
FDA's QMSR has moved US quality system requirements much closer to ISO 13485, effectively harmonising the two, though some FDA-specific expectations still sit on top. Building a QMS that satisfies both from the outset saves you maintaining two separate systems side by side.
The FDA expects analytical and clinical performance data appropriate to your device's risk and intended use, generally designed and documented in line with CLSI guidelines for laboratory method validation. The depth of evidence scales with your pathway, as a 510(k) needs less than a PMA, so it pays to scope your studies against the right bar from the start.
Still have questions? Contact us and we'll be happy to help.
