CE Marking and FDA Approval for a Lateral Flow Cassette Reader as Lab Equipment.

Good morning. Here are some inputs that can help you identify and pursue the next steps.

To best identify all the applicable regulations and requirements, you can follow these steps:

1. Define the indications for use of your product
2. Define the scope of your medical device/IVD
3. Outline the clinical risks (from a safety and efficacy perspective)
4. Identify product classification

If your product is low, medium or high risk, it would be classified by the UDFDA, as a class I, II or III respectively. For the EU your IVD would be classified as per the IVDR in one of the four (A to D) classes, from Class A being the lowest risk to Class D being the highest risk.

For the EU market the typical requirements are as follows:

1. Conformity Assessment:You have to demonstrate that the lateral flow cassette reader complies with relevant safety and performance requirements. This assessment includes:
   • Technical Documentation: Comprehensive documentation detailing the design, manufacturing, and performance characteristics of the device.
   • Risk Assessment: Identification and evaluation of potential risks associated with the device.
   • Clinical Evaluation: For devices requiring clinical data, a systematic process to assess the performance and safety based on clinical evidence.
2. Notified Body (NB) Involvement: Depending on the device's classification, involvement of a notified body may be required for conformity assessment.
3. Quality Management System (QMS): You have to maintain a quality management system in accordance with ISO 13485, and obtain its certification.
4. Declaration of Conformity: Once the device has successfully undergone the conformity assessment, you can do a Declaration of Conformity, stating that the product complies with relevant regulations.
5. CE Marking: With a completed conformity assessment and Declaration of Conformity and/or NB review/approval, a CE Mark can be affixed on the lateral flow cassette reader.
6. Post-Market Surveillance: You would have to establish processes for post-market surveillance to monitor the device's performance and address any issues that may arise after it is placed on the market.

For the US market, the typical requirements are as follows:

1. Quality System Regulation (QSR): Implement a Quality System that complies with the FDA's Quality System Regulation (21 CFR Part 820). This includes establishing and maintaining procedures for design controls, production controls, and post-market surveillance.
2. Labeling and Reporting: Ensure that the device's labeling meets FDA requirements. You must also adhere to adverse event reporting requirements, submitting Medical Device Reports (MDRs) for certain adverse events.
3. Performance Testing: Conduct performance testing to demonstrate that the lateral flow cassette reader meets specified safety and effectiveness criteria. Performance data should be included in the 510(k) submission, if applicable and determined to be the right route for marketing authorization.
4. Post-Market Surveillance: Establish a system for monitoring and addressing post-market issues. Timely reporting of corrections and removals is essential for maintaining compliance.
5. Clinical Studies (if applicable): Depending on the device's classification and intended use, clinical studies may be necessary to support safety and effectiveness claims. This is more common for Class III devices.
6. Registration and Listing: Register the manufacturing establishment and list the lateral flow cassette reader with the FDA. This is done through the FDA Unified Registration and Listing System (FURLS).
7. Unique Device Identification (UDI): Comply with UDI requirements by assigning and labeling each device with a unique identifier. UDI compliance enhances traceability and facilitates post-market surveillance.
8. FDA Inspections: Be prepared for FDA inspections. The FDA may conduct inspections to ensure that manufacturing processes, quality systems, and other aspects comply with regulations.
9. Advisory Opinions: You can seek FDA guidance through the Pre-submission Program or by requesting an Advisory Opinion to address specific regulatory questions.
10. Marketing authorization: Depending on the indications for use of the product and the scope of the application, you may have to pursue a 510k clearance or a DeNovo approval.

In case you need more assistance, you can contact our experts at [email protected] or visit our website The Best Regulatory Consultant Across The Globe | Elexes

Hope this helps.

Best,
Parul Chansoria