Jane Pine Wood featured in publications regarding the FDA's Final Rule on laboratory developed tests


Jane Pine Wood, of our Healthcare Practice Group, published an insightful blog post regarding the FDA's long-anticipated Final Rule regulating laboratory developed tests (LDTs). She was recently interviewed by two publications for her knowledge on this Final Rule and its implications. 

GenomeWeb and 360Dx reporter, Greg Cima, featured her insights in his story "Under LDT Final Rule, Labs May Face Tough Choices Between FDA, New York Regulatory Paths for Tests."

An excerpt from the article is below.

Jane Pine Wood, a lawyer for the law firm McDonald Hopkins, said that seeking CLEP approval for an LDT is easier than an FDA review but it remains a substantial hurdle that is more difficult than seeking CLIA certification or College of American Pathologists (CAP) accreditation. She noted that some labs have in the past opted to offer their LDTs across only most of the country, excluding New York, because of the difficulties in both securing CLEP approvals and in-network coverage from payors in the state.

Pine Wood said that New York may have difficulty finding sufficient numbers of qualified laboratorians in response to a surge of applications from out-of-state labs that had not previously provided testing for New York patients. Those professionals may be in higher demand by CLEP and FDA for processing applications as well as for labs that are seeking approvals.

To read the full article, click here.

She was also featured in the June issue of Laboratory Economics Compliance & Policy Report.

An excerpt is below.

The proposed rule basically said everything is an in vitro diagnostic (IVD) product, and the final rule basically says the same thing. The critical element is the 500 pages of preamble in which the FDA discusses its rationale for the rule and its exercise of enforcement discretion. The categories of enforcement discretion set forth in the preamble discussion are not exceptions or grandfathering that most people think of as exceptions or grandfathering. Most people think if there are exceptions or
grandfathering, it’s carved in stone. Instead, the FDA can modify, expand or remove any of these categories of enforcement discretion at any time.

To read more about Laboratory Economics or subscribe to receive its issues, click here.

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