HMC questions in the FDA’s 2022 IVD town halls
Public transcripts document questions about respiratory diagnostic studies, sample handling and home collection.
A public historical record
Three FDA town-hall transcripts from 2022 record speakers identifying themselves with Hopkins MedTech Compliance. On 18 May, Wendy asked about clinical evidence for a molecular 510(k), and Homer Wu raised a pre-EUA combination-test question. On 24 August, Homer discussed a proposed multi-country influenza B study. On 21 September, Jennifer Stanford asked about retrospective recruitment and specimen splitting, and Homer discussed home-collection validation.
Read each exchange in context
The exchanges concern particular questions during the COVID-19 and monkeypox public health emergencies. FDA responses emphasized matters such as the proposed study and the relevant submission context. Readers should consult the complete transcripts, including the agency’s qualifications, rather than reuse an isolated answer as current general guidance.
What participation establishes
These records document participation in public discussions. They do not establish FDA endorsement of HMC, authorization of a company product, or acceptance of a later clinical study. For a new project, current requirements and the product-specific evidence plan need a fresh review.
Sources & further reading
Read the original company post on LinkedInFDA IVD town hall — 18 May 2022FDA IVD town hall — 24 August 2022FDA monkeypox town hall — 21 September 2022Adapted from a public company post, with sources checked on 8 October 2026. Original post dates are preserved; the website summary is not attributed to an individual employee.
