Signons from Lyme Group Leaders on FDA Test Takeover
The Lyme Disease Association, Inc. (LDA) has formulated a response to FDA to be included in its comment period on its testing Guidance which will affect specialty lab Lyme tests. Therefore, groups who want to support the position taken by the LDA may join in on the letter. LINK TO HISTORY OF FDA GUIDANCE ACTIVITY
- Please post and/or distribute this information widely to groups or provide link to LDA website www.LymeDiseaseAssociation.org for this information.
- Only the one Lyme group leader authorized by the group can sign onto the letter and must provide valid contact information. All groups welcome. No individuals, sorry. (Individuals see below Group Signon)
- Read full letter here. LDA LETTER TO FDA WITH 73 GROUPS SIGNED ON
- Signons to the response letter need to be entered on the LDA website form by 12M ET, January 27, 2015.
GROUP SIGNON HERE
All fields below are required, but the letter will contain name of group, contact name, and email only.
Letter was submitted with 73 groups signed on.
INDIVIDUALS READ THIS
Any individual who has not yet taken the Lymedisease.org survey on FDA testing takeover, can do so by clicking here.
BRIEF HISTORY: FDA is moving forward in the process of finalizing its new Laboratory Developed Test (LDT) Guidance proposal. The proposal would move LDTs from under the jurisdiction of Clinical Laboratory Improvement Amendment (CLIA) regulated by Medicare & Medicaid Services to under the jurisdiction of the Food & Drug Administration (FDA). The FDA now regulates non-LDT lab tests under “medical devices,” and “approves” or “clears” tests. Non LDTs are tests which are sold to other laboratories while LDTs are generally tests which are developed and used in one lab, commonly called specialty labs.