Posted: 26 Jan 2017 07:12 PM PST
By Allyson B. Mullen & Jeffrey N. Gibbs –
In late November, FDA announced that it would not be finalizing the 2014 draft LDT Guidance. The Agency had, however, done a significant amount of work regarding the draft guidance and evaluating the regulatory framework for lab tests. In an effort to document the work that it had done and further the public discussion regarding LDTs, FDA issued a discussion paper on Friday (the 13th) laying out key elements of a possible revised future LDT regulatory framework.
Released in the last week of the Obama administration, the discussion paper is in no way a formal proposal by FDA. We think, however, it is worth noting a few key elements that could potentially appear in a renewed attempt to regulate LDTs in a new administration. The discussion paper states the following:
The discussion paper does, however, make clear that FDA believes compliance wouldn’t be too burdensome for laboratories. Whether that assessment is correct is debatable. For example, the discussion paper says that “clinical validity, especially of established tests, can often be supported by literature, well-curated databases, or other appropriate sources that meet the valid scientific evidence standard.” As we have previously noted, FDA rarely accepts data other than prospective clinical studies; even performing studies using banked samples can be difficult. It is possible that third-party reviewers may be more accepting of alternative forms of clinical data; however, we do not expect FDA would change its standards.
As is so often the case, the devil is in the details. Assuming FDA does resume its quest to regulate LDTs, we will have to wait quite a while to learn the details.
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