New Rules for FDA Regulation of Lab Developed Diagnostic Tests (LDT)

Duration: 60 Minutes
On 31 July 2014 FDA announced new rules for regulating LDTs, and then on 3 Oct 2014, FDA released 2 new guidance documents detailing the new rules for regulating LDTs. Since the 1976 passage of medical device regulations, LDTs had been barely regulated. Currently there are more than 4000 LDTs offered by hundreds of labs across the country. These new rules intend to change the entire landscape of LDT regulation by FDA.
laboratory tests
Instructor: Mukesh Kumar
Product ID: 500745

Under these rules, there is a new classification for LDTs based on the perceived risk, and new rules for registration, testing, approval and adverse event reporting requirements for LDTs. In the near future, FDA intends to apply enforcement discretion for the premarket approval requirements and quality system regulations, but these discretions will also be phased out in the next few years.

Why Should you Attend:
Since the announcement of these rules, there has been intense discussion on the utility and practicality of these rules. The industry is worried that these may discourage innovation and access to widely used tests now routinely used by healthcare professionals. On the other hand, FA strongly believes these rules are needed in the current landscape where these tests are widely used and raise significant concerns about their safe use by patients and physicians alike.

This webinar will discuss the current rules and practical tips for being compliant. The instructor will also provide advice based on his extensive regulatory experience on the best and worst case scenarios for various kinds of LDTs under the current regulations.

The presentation is intended for general instructions to all LDT providers such as laboratories, clinics, physicians, hospitals, reimbursement experts, clinical trial users, and regulators who wish to have a better understanding of how FDA intends to regulate LDTs.

Objectives of the Presentation:
The objectives of the presentation are to have a wide discussion on:
  • New LDT classification system
  • Regulatory categories for different LDTs
  • Current FDA regulations and guidance documents
  • Registration of LDTs
  • Documentation required
  • Quality systems currently applicable to LDT providers
  • Labeling and marketing practices
Who can Benefit:
  • Senior management of LDT providers
  • Project Managers
  • Regulatory Vice Presidents, Directors and Managers
  • Lab testing professionals
  • Compliance professionals
  • Auditors
  • Attorneys - In-house or Outside Counsel
$375
Recorded Session for one participant
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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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