Laboratory-Developed Tests - Medical devices 2017

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Category Laboratory-Developed Tests, Medical Device Webinars, FDA Trainings, FDA withdrawing guidance, guidance for LDT devices, Regulatory Specialist management controls, Why does FDA Can Regulate Them

Deadline: August 09, 2017 | Date: August 10, 2017

Venue/Country: Online, U.S.A

Updated: 2017-06-15 15:13:57 (GMT+9)

Call For Papers - CFP

This presentation will review the legal definition of medical device, and how

it is applied by FDA to in vitro diagnostic tests. It will review the history of

FDA interest in LDTs, and will describe the current situation with respect to

Laboratory-developed tests.

Why should you Attend:

This 1 hour session will explore the reasons FDA has for claiming such

jurisdiction, and the objections to FDAs' position articulated by the clinical

laboratory community, and others.

Areas Covered in the Session:

"Enforcement Discretion" and how it has been applied to LDT regulation

Extent of CLIA '88 authority over LDT performance

Role of US Congress in answering the question of FDA authority

International (EU) approach to LDTs

Who Will Benefit:

QA Specialist

Complaint Coordinator

Regulatory Specialist

QA Manager

QA Trainer

All above in Medical Device companies

Speaker Profile:

Anna Longwell is currently principal attorney of the Palo Alto Law firm,

Longwell and Associates, which specializes in Food and Drug law. The firm

has expertise in US FDA expectations, regulation and law, affecting the

development and ultimate marketing of new medical products, drugs,

devices and biologics. They have served the regulatory needs of large (>$2

billion/year) divisions of Fortune 500 companies, and small (4 person)

biotech start-ups.

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: supportcompliance4All.com