Every regime ยท United States
FDA in vitro diagnostic regulation
In vitro diagnostics are medical devices under FDA rules, with the added CLIA complexity categorisation that decides where a test can be run, and labelling for prescription or over-the-counter use.
named This regime is named, not quoted: what it covers and the documents it expects are described in our own words, and no requirement text is reproduced. On the sheet its chip is outlined; a product whose regimes are all named stands as reference.
What it expects in the file
- Technical file
The technical documentation: design, drawings, bill of materials, the standards applied, the conformity assessment route, and the evidence that the requirements are met. Kept for the retention period the regime sets, typically ten years from the last unit placed on the market. - Risk assessment
The documented hazard identification and risk assessment for the product across its lifecycle, updated when the design, the use or the field data changes. - Test reports
Test reports from an accredited or accepted laboratory against the standards the technical file names, tied to the exact model and revision tested. - Labelling and instructions
Markings on the product and packaging (conformity mark, identification, warnings, manufacturer and importer details) and the instructions and safety information in the language of the market. - Traceability records
Batch, lot or serial identification on the product, the records that tie a unit to its production and supply chain, and UDI where the device rules require it. - Post-market surveillance plan
The plan and the periodic reports for collecting and acting on field experience, complaints and incidents, in the form the device rules set. - Registrations
Producer, establishment, device or product registrations in the databases the regime names (EUDAMED, EPREL, CPNP, the WEEE and battery registers, FDA registration and listing). - Third-party certificate
A type-examination certificate, notified or approved body certificate, or listing from a recognised laboratory, with the scope and the expiry.
Duties that continue after sale
- Market surveillance cooperation
Answer an authority's request for the technical file, the declaration and the supply chain within the time it sets, in a language it accepts, and cooperate with any corrective measure it requires. - Incident reporting
Notify the authority when a product has caused, or could cause, an accident, injury or serious incident, through the channel the regime names (the Safety Business Gateway, the MHRA, the FDA, SaferProducts.gov) and within its clock. - Recall readiness
Be able to identify affected units, reach the customers who hold them, issue a notice in the required form, offer the remedy the rules require, and show the authority the effectiveness of the action. - Traceability records
Keep the records that identify which batch went to which customer, and the identification on the product that lets a unit be traced back, for the retention period the regime sets. - Post-market surveillance and periodic reporting
Run the surveillance plan, analyse complaints, trends and field data, and produce the periodic safety update report the device rules require.
Product categories that engage it
See which of your products engage it
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