May Event: Point-of-Care IVDs and CLIA Waiver


Monthly Program:

Wednesday, May 16th 2018

Point-of-Care IVDs and CLIA Waiver


Program Speaker:

Erika Ammirati, RAC, MT (ASCP)


Ammirati Regulatory Consulting

Los Altos, CA

Event Agenda: Date:

Wednesday, May 16th, 2018

Time: 5:15 – 6:00 PM Registration & Snacks

6:00 – 6:05 PM Welcome and Announcements

6:05 – 7:05 PM Program Presentation

7:05 – 7:30 PM Q & A


BD (former CareFusion)

3770 Torrey View Court

San Diego, CA 92130

View Map Program Topic:

Diagnostic testing has slowly but steadily moved out of the central laboratory and into testing sites closer to patients. This testing modality, referred to as point-of-care (POC) testing, has enabled laboratory service providers to perform testing anywhere the patient is located, including outpatient clinics, nursing homes, the patient's home, and at the hospital bedside. However, this shift has forced manufacturers of in-vitro diagnostic (IVD) medical devices to face new questions when bringing their devices to market; namely with regard to how FDA categorizes diagnostic tests. In January 2000, the responsibility for categorization of commercially available IVD tests was transferred from the Centers for Disease Control and Prevention (CDC) to the FDA Center for Devices and Radiological Health (CDRH). This allowed IVD manufacturers to submit 510(k) premarket notifications or PMA applications for tests and requests for complexity categorization of these tests under CLIA to one agency. Categorization is based on their complexity—from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests. This program will help attendees understand the language surrounding these devices and their regulatory considerations.

Program Summary:

This presentation will provide attendees with an understanding and overview of POC IVDs and CLIA Waivers.

In this program, attendees will:

  • Learn about the basic POC IVD requirements and understand the various levels of complexity based on the type of test

  • Understand the regulatory concerns and clinical requirements surrounding POC IVDs

  • Have a better understanding of CLIA Waivers and how FDA evaluates CLIA categorization as part of the 510(k)/PMA process

  • Be able to identify the three routes to CLIA Waiver (i.e. cleared for home use, waived by regulation or waiver petition)

  • Understand the qualitative and quantitative data requirements used to demonstrate accuracy and precision in CLIA Waiver studies

  • Learn about Dual Submissions based on new FDA guidance that combines the 510(k) and waiver petition in one filing

Speaker Biography:

Erika Ammirati, RAC, MT (ASCP) is an independent regulatory consultant to industry located in Los Altos, CA. Ms. Ammirati specializes in the areas of clinical trials and product approvals for diagnostics and devices, with an emphasis on POC and over-the-counter diagnostics. She is also well-versed in CLIA regulations and has brought several POC diagnostics through the CLIA waiver process. Prior to becoming a consultant over 20 years ago, Ms. Ammirati gained over 10 years industry experience in IVD firms, preceded by a 10-year career in the clinical laboratory as a medical technologist. Ms. Ammirati is a past Industry Representative on two FDA Advisory Panels, and is the co-author of numerous publications; she holds a BS degree in Genetics from the University of California, Davis, and current California State licensure in Medical Technology. She is also certified as a regulatory professional through RAPS (Regulatory Affairs Professional Society).

Please make your reservation early. The online registration due date is Monday, May 14th 2018. Credit Cards are accepted online only. Cash and Check are accepted at the door.

Online Pre-registration (through Monday May 14th, 2018): $15 SDRAN Member, $25 Non-Member

Onsite Registration: $25 SDRAN Member, $35 Non-Member

For Questions Email:


From the North 5:

I-5 South toward San Diego

Exit toward Carmel Mountain Rd

Left onto Carmel Mountain Rd

Left onto Torrey View Court

Facility is on the right

From the South 5:

I-5 North toward Del Mar

Merge onto I-5 local Bypass

Take Carmel Mountain Rd exit (32)

Turn right onto Carmel Mountain Rd

Turn left onto Torrey View Court

Facility is on the right