SENT VIA EMAIL
February 4, 2022
Janet Woodcock, MD
Acting Commissioner
United States Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
[email protected]
RE: Accessible Instructions for At-Home COVID-19 Test Kits
Dear Commissioner Woodcock:
On January 11 I wrote to you regarding the urgent need for the Biden administration to procure at-home COVID-19 test kits that are accessible for blind Americans as a part of the administration’s national test kit distribution plan.1 Though the NFB has not yet received a response from your office, I write to you again to call to your attention how the FDA continues to move forward without considering equal access for blind Americans and to request immediate action. Specifically, at-home COVID-19 test kit instructions posted to the FDA’s website are inaccessible with the screen access software blind Americans use and must be remediated to align with Section 508 requirements and to provide equal access to this critical information.
For blind Americans to be able to use at-home COVID-19 test kits, the instructions must be available nonvisually. As you know, Section 508 of the Rehabilitation Act requires information and communication technology developed, procured, maintained, or used by the federal government to be accessible to individuals with disabilities. The instructions currently posted at www.fda.gov are missing necessary accessibility mark-up including alternative text for images, meaningful heading structure, proper coding for elements such as tables, and/or other mark-up. Without this, blind Americans cannot access the test kits' instructions as they are intended to be followed. Missing and non-sequential information yield incorrect test instructions that can result in invalid or inaccurate test results.
The National Federation of the Blind urges FDA to follow its own guidance regarding PDF accessibility—https://www.fda.gov/about-fda/internet-accessibility/requirements-checklists-section-508—and promptly remediate all COVID-19 test kit instructions posted to www.fda.gov, including those listed below. We recommend the instructions also be made available in HTML to support broader access to the content.
- BD Veritor At-Home COVID-19 Test: https://www.fda.gov/media/151761/download
- BinaxNOW COVID-19 Ag Card 2 Home Test: https://www.fda.gov/media/147259/download
- BinaxNOW COVID-19 Ag Card Home Test: https://www.fda.gov/media/144574/download
- BinaxNOW COVID-19 Antigen Self-Test: https://www.fda.gov/media/147254/download
- CareStart COVID-19 Antigen Home Test: https://www.fda.gov/media/151248/download
- Celltrion DiaTrust COVID-19 Ag Home Test: https://www.fda.gov/media/153420/download
- CLINITEST Rapid COVID-19 Antigen Self-Test: https://www.fda.gov/media/155175/download
- SD Biosensor COVID-19 At-Home Test: https://www.fda.gov/media/155126/download
- Ellume COVID-19 Home Test: https://www.fda.gov/media/144593/download
- Flowflex COVID-19 Antigen Home Test: https://www.fda.gov/media/152698/download
- iHealth COVID-19 Antigen Rapid Test: https://www.fda.gov/media/153923/download
- InteliSwab COVID-19 Rapid Test: https://www.fda.gov/media/149911/download
- InteliSwab COVID-19 Rapid Test Rx: https://www.fda.gov/media/149906/download
- MaximBio ClearDetect COVID-19 Antigen Home Test: https://www.fda.gov/media/155635/download
- QuickVue At-Home COVID-19 Test: https://www.fda.gov/media/146312/download
- QuickVue At-Home OTC COVID-19 Test: https://www.fda.gov/media/147265/download
- SCoV-2 Ag Detect Rapid Self-Test: https://www.fda.gov/media/154336/download
- Cue COVID-19 Test: mhttps://www.fda.gov/media/138826/download
Without accessible instructions, blind individuals cannot privately and independently administer these potentially life-saving tests. Please let us know when the aforementioned instructions are remediated so that we can share the information with blind Americans nationwide.
Sincerely,
Mark A. Riccobono, President National Federation of the Blind
cc: Kimberly Knackstedt, Director of Disability Policy for the Domestic Policy Council at The White House, [email protected]
Osaremen Okolo, Policy Advisor for The White House Office on COVID-19 Response, [email protected]