Tuesday, July 16, 2024

FDA Holds Webinar on Categorization of In Vitro Diagnostics: Relevant to FDA LDT Regulation

In May, the FDA announced a five-year plan to regulate lab-developed tests, although a court challenge is already underway.

On July 16, 2024, FDA provided a 45-minute webinar on categorization of in vitro diagnostics (IVDs), which is highly relevant for labs that will now need to, or want to, submit 510(k) and PMA applications.

I've provided a captured audio recording, an (imperfect) video screen capture, an "auto-transcript" of the webinar, and an AI summary of key points.   

In the last 15 minutes, FDA answered several pre-submitted questions.  See a summary of the 8 questions below.

See a rapid summary of the webinar by Christine Bump, at Linked In, here.

FDA MATERIALS

The webpage for the new plans for FDA LDT oversight is here:
https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests
Here is the 39-slide deck:

MY MATERIALS:

FDA may later provide a high quality YouTube link and a high quality transcript.  In the meantime, I have rough versions "FYI."

An auto transcript:

At YouTube, an audio recording I made, which is fine, and a video capture, which is imperfect. 


AI CORNER

Here is an AI summary of the 45 minute webinar:

Report on FDA Webinar: Categorization of Diagnostic Test Devices (IVD)

Date: July 16, 2024

Overview [Chat GPT 4]

On July 16, 2024, the FDA conducted a webinar focused on the categorization of in vitro diagnostic (IVD) devices. This session is particularly relevant for laboratories preparing for 510(k) and PMA submissions in the upcoming years, following the FDA's recent regulation mandating the review of lab-developed IVD tests. This report summarizes the key points from the webinar and provides a detailed summary of the Q&A session.

Key Points from the Webinar

1. IVD Classification System

  • The FDA uses a risk-based classification system to ensure the safety and effectiveness of medical devices, including IVDs.
  • Devices are classified into three categories: low risk (Class I), moderate risk (Class II), and high risk (Class III).
  • The classification is based on factors such as intended use, technological characteristics, patient population, and the context of use.

2. Regulatory Controls

  • General Controls: Apply to all medical devices unless exempted by regulation. These include labeling requirements, medical device reporting, establishment registration, device listing, and quality system requirements.
  • Special Controls: Specific to Class II devices, including performance standards, special labeling requirements, post-market surveillance, and premarket data requirements.

3. Premarket Review Pathways

  • 510(k) Premarket Notification: Generally for moderate risk (Class II) devices, where manufacturers must demonstrate that their device is as safe and effective as a legally marketed predicate device.
  • Premarket Approval (PMA): Required for high-risk (Class III) devices, demonstrating reasonable assurance of safety and effectiveness.
  • De Novo Classification: For novel devices that are low to moderate risk and have no predicate device. This pathway provides a means to classify new types of devices as Class I or II.

4. Product Classification Database

  • The FDA maintains a product classification database that includes information on all medical devices, their classification, product codes, and regulatory requirements.
  • Manufacturers are encouraged to use this database to determine the appropriate classification and regulatory controls for their devices.

5. Pending: Reclassification Process

  • The FDA follows a formal process to reclassify devices, which includes issuing a proposed order, convening a classification panel, considering public comments, and issuing a final order.
  • Many Class III tests, including companion diagnostics and infectious disease, will be reclassifed as Class II by this process.  This plan was announced by FDA in January 2024 and is ongoing.

Summary of Q&A Session

Q1: Does FDA classify laboratory-developed tests (LDTs) as test systems including instrumentation and sample preparation?

  • Answer: FDA classifies IVDs, including LDTs, as test systems comprising components like reagents, instruments, and other articles that function together to produce a test result. Classification is based on the intended use and risk of the test system.

Q2: If an IVD test system’s intended use matches a classification regulation but uses a different sample matrix or technology, can it be classified under the same regulation?

  • Answer: Generally, yes. However, if the differences in specimen type or technology raise different safety and effectiveness questions, the classification regulation would not be appropriate.

Q3: How does FDA classify an LDT that includes components labeled for Research Use Only (RUO) by another manufacturer?

  • Answer: Laboratories can use RUO components in their LDTs if they qualify these components and appropriately manage them under their quality system. These components will be reviewed in the premarket submission for the LDT.

Q4: Are laboratory information management systems (LIMS) incorporated in the classification of IVD test systems?

  • Answer: Generally, LIMS are not included as part of IVD test systems and are regulated under their own classification regulation (21 CFR 862.2100, Product Code JQP).

Q5: How does a laboratory manufacturer determine the type of premarket submission required for a test that is not classified?

  • Answer: Laboratories should start by searching the product classification database. If the IVD is not listed, manufacturers should assess the risk of the IVD. High-risk IVDs likely require a PMA, while low to moderate risk IVDs may be eligible for De Novo classification.

Q6: What does FDA mean by "low risk"?

  • Answer: Low risk devices pose minimal potential for harm and are generally Class I devices.

Q7: What is an FDA product code?

  • Answer: A product code identifies the generic category of a device for FDA classification. Each classification regulation may have multiple product codes associated with it, used to delineate technology and indication subgroups.

Q8: What is the process for reclassification?

  • Answer: The FDA follows a formal process that includes issuing a proposed order, convening a classification panel, receiving and considering public comments, and issuing a final order.

Conclusion

The FDA webinar provided comprehensive insights into the classification and regulatory requirements for IVD devices. The detailed guidance on utilizing the FDA's product classification database and understanding the premarket submission pathways will be invaluable for laboratories planning their submissions in light of the new regulations on lab-developed tests.

For more detailed information, laboratories are encouraged to review the webinar slides and visit the FDA's website for additional resources and upcoming webinars.   [End Chat GPT 4]