Tell FDA How New LDT Rules Will Affect Infectious Disease Testing and Patient Care

Nov. 10, 2023

The Food and Drug Administration (FDA) is proposing strict new regulations on laboratory-developed tests (LDTs). Once enacted, these rules could have significant harmful effects on clinical microbiology laboratories and the patients they serve. 

Share With the FDA How These New Rules Will Affect the Work of Medical Microbiologists

We need you to share with the FDA how these new rules will affect your work. While ASM will also be submitting comments, the FDA must also hear from those of you who work in the lab. ASM opposes the proposed rule as written because it will phase out enforcement discretion for all LDTs and regulate them under the medical device authority. Such discretion is essential for “low risk” testing and is consistent with the realities of how most LDTs are used in infectious disease patient care.

The most effective thing you can do is to send personalized comments to the FDA. Comments are due to the FDA by Dec. 4.

Step-By-Step Instructions for Submitting Personalized Comments to the FDA

It’s important to follow each of these step-by-step instructions, as some fields are required. Also, because there are character limits, we recommend that you draft a separate document to be uploaded. 
  1. Download the letter template provided below and customize it by providing your perspective on any (or all) of the questions. Save and rename the document. It will be uploaded in Step 5.
  2. Go to the Medical Device LDT Comment Page.
  3. Paste and edit the following text in the “Comment” section: My name is [your name] and as a microbiologist at [your institution] I’m writing to voice my concerns for the proposed rule on laboratory-developed tests (LDTs). As written, the rule does not take into account the unique nature of infectious disease testing. While I support FDA’s goal of ensuring the safety and accuracy of LDTs, when it comes to infectious diseases, the rule may in fact have the opposite effect by limiting patient access to vital testing for pathogens. Please find my full response to the rule in the attached letter.  
  4. Under “What is your comment about?” select “Health Professional A0007” from the dropdown menu on the comment page.
  5. Upload your document as an attachment. Please note that if you plan to upload more than one attachment, it’s recommended to use the following naming format: Attachment1_<insert title of document>, Attachment2_<insert title of document>, Attachment3_<insert title of document>.
  6. Provide your email address in the field.
  7. Select “An Individual.” 
  8. Complete Captcha.
  9. Submit your comments.
  10. After submitting your comments to the FDA, please send a copy of your comments to 
Please use the document below as the template for your attachment and personalize the letter where highlighted. You do not need to address all the highlighted areas; just be sure to remove the ones you do not use before you submit your comments.


Author: ASM Advocacy

ASM Advocacy
ASM Advocacy is making it easy and providing opportunities for members to advocate for evidence-based scientific policy.