Share this e-Alert:

Polsinelli - Health Care Polsinelli - Health Care Polsinelli - Health Care Polsinelli - Health Care Polsinelli - Health Care Polsinelli - Health Care Polsinelli - Health Care


January 2017


FDA's 'Conversation Starter' Paper Suggests Altered Approach for Laboratories







For more information about this e-Alert, please contact:


Barry D. Alexander


Email | Bio


Carey B. Nuttall


Email | Bio


Cybil G. Roehrenbeck


Email | Bio


Jessica D. Schmit


Email | Bio


To learn more about our Health Care practice, to contact one of our Health Care attorneys, or for more Health Care Intelligence, click here.



Polsinelli - Health Care Polsinelli - Health Care Polsinelli - Health Care Polsinelli - Health Care View Polsinelli documents on JD Supra  


LinkedIn Twitter Facebook Polsinelli Podcast

While a new U.S. Food & Drug Administration discussion paper neither serves as legal guidance nor effects any immediate policy changes, its issuance does suggest that the FDA may take a less stringent approach to regulating Laboratory Developed Tests (LDTs) in the future than previously understood by laboratories and other stakeholders.

The paper, published on January 13, provides a review of LDT guidance previously proposed by the agency and an analysis of public comments and feedback received from stakeholders.  The FDA's consideration of appropriate LDT oversight has been ongoing for a number of years.  In 2014, the agency proposed a new oversight scheme for LDTs, drawing the criticism of many industry participants that the FDA would be over-regulating this type of testing.  In November of 2016, the FDA announced that it would not finalize its 2014 proposed guidance, signaling that opposing arguments that LDT oversight should be incorporated within Clinical Laboratory Improvements Act (CLIA) oversight and other mechanisms may have carried weight.

The new LDT Discussion Paper indicates that only a certain subset of new or significantly modified tests would require premarket approval under the LDT oversight framework proposed by FDA; the vast majority of existing tests would be grandfathered in and even some new LTDs, such as testing for rare or low-risk diseases or those used for forensic purposes, would be exempt from premarket review by FDA. The FDA suggests that even those LTDs requiring approval, which would mainly be for moderate and high risk diseases, may not find the process challenging, indicating that medical and scientific literature and databases may be enough to support the necessary validity of a test. Existing tests would only be subject to such a review if malfunctions or associated patient harm were reported. The paper further emphasized the importance of transparency in the approval process of a new LTD, proposing publication of validity testing.

The Discussion Paper also outlined a more rapid implementation of any new LDT oversight framework than originally proposed, with a full rollout expected to occur within four years, as opposed to the 2014 guidance, which suggested a 9-year timeline. In part, this appears to be based on the FDA's new focus on a collaborative approach to the oversight, by suggesting different roles other stakeholders may take in the oversight process to "best streamline effective oversight by taking advantage of each federal agency's existing structure and strengths." Food and Drug Admin., Discussion Paper on Laboratory Developed Testes (LDTs), at 2 (2017). The paper indicates the FDA's willingness to coordinate and share regulatory responsibility with the Centers for Medicare & Medicaid Services (CMS), which promulgates CLIA; in fact, the FDA suggested that its aim for any potential LDT oversight framework would be to complement existing CLIA requirements, not duplicate them. Furthermore, the FDA plans to share some of the reviewing burden with a variety of third-party programs, leveraging its existing relationship with New York State's Clinical Laboratory Evaluation Program and organizations that are CLIA-approved to offer laboratory accreditation.

The FDA indicated that the paper serves as a "conversation starter," while the agency continues to receive public feedback for an undisclosed period of time on the matter and best determines how to balance patient safety concerns with burdensome and costly regulations and undue hardship on innovation.  Although the FDA released its last LDT-related publication backpedaling on its stricter 2014 guidance almost immediately after the 2016 election, it is nonetheless unclear how the Trump administration will impact the final regulations or their implementation.

For More Information

If you have questions regarding this alert, please contact one of the authors, a member of Polsinelli's Health Care Practice, or your Polsinelli attorney.







Atlanta  Boston  Chattanooga  Chicago  Dallas  Denver  Houston  Kansas City  Los Angeles  Nashville  New York
Overland Park  Phoenix  Raleigh  San Francisco  Silicon Valley  St. Joseph  St. Louis  Washington, D.C.  Wilmington








real challenges. real answers.SM  
Polsinelli is an Am Law 100 firm with more than 800 attorneys in 20 offices, serving corporations, institutions, and entrepreneurs nationally. Ranked in the top five percent of law firms for client service*, the firm has risen more than 50 spots over the past five years in the Am Law 100 annual law firm ranking. Polsinelli attorneys provide practical legal counsel infused with business insight, and focus on health care, financial services, real estate, intellectual property, mid-market corporate, labor and employment, and business litigation. Polsinelli attorneys have depth of experience in 100 service areas and 70 industries. The firm can be found online at Polsinelli PC. In California, Polsinelli LLP.

* 2017 BTI Client Service A-Team Report







Polsinelli provides this material for informational purposes only. The material provided herein is general and is not intended to be legal advice. Polsinelli is very proud of the results we obtain for our clients, but you should know that past results do not guarantee future results; that every case is different and must be judged on its own merits; and that the choice of a lawyer is an important decision and should not be based solely upon advertisements.

Copyright © 2017 Polsinelli PC.

Connect with us on LinkedIn. Connection with us on Twitter. Connect with us on Facebook. Polsinelli Health Care Technology Health Care