Educating IVD Manufacturers - An Undertaking by FDA's Office of In-Vitro Diagnostics

FDA/CDRH/OIVD is committed to educating inventors and manufacturers about its requirements for approval. Concomitantly, we understand that you are concerned and eager to learn about their expectations. You may not know FDA's special requirements for "home use" tests, their meaning of "intended use" or "clinical utility", or when the use of human samples is subject to the informed consent and IRB requirements of Parts 50 and 56. Clinical Device Group and the Food and Drug Law Institute are proud to present the staff of FDA/CDRH/OIVD in the e-conference: EDUCATING OIVD MANUFACTURERS.

Objective:
This 3-hour e-conference will present an opportunity for you to learn the latest thinking from OIVD on best practices for IVD development. The staff of the Office of In Vitro Diagnostics will discuss the study, quality, and pre-IDE expectations for the commercialization of new in vitro diagnostic tests.

Agenda:
1. Introduction—Steve Gutman Ph.D.—5 minutes
2. In Vitro Diagnostic (IVD) Device Studies—Sally Hojvat Ph.D.—45 minutes
3. Overview of the Quality System regulation—Tonya Wilbon B.S., M.S. (ASCP)—45 minutes
4. Pre-IDEs—Sousan Altaie Ph.D.—45 minutes
5. Questions and Answers—30 minutes

You will learn:
1. To understand the FDA's current thinking on the IVD Studies.
2. The Seven-Major-Subsystems approach to a Quality System.
3. That pre-IDE is a streamlined regulatory method in which the FDA and the sponsor agree on the criteria and data necessary to insure safety and efficacy of devices prior to the start of preclinical and clinical trials.
4.That pre-IDE is the current agency’s thinking, an extremely flexible framework for product development, and that does not bind the FDA or the sponsor.

Who Should Attend:
This e-conference is designed for regulatory and clinical affairs specialists, attorneys, senior management, or marketing people, who plan, manage, oversee, or conduct medical device clinical trials or use the results therefrom.

Presenters:
Steve Gutman Ph.D.—Introductions
The Director of the OIVD, Office of Compliance, CDRH, FDA, will introduce our speakers.

Sally Hojvat Ph.D.—In Vitro Diagnostic (IVD) Device Studies
Two main objectives should be considered when conducting an IVD study. These are to produce valid scientific evidence demonstrating reasonable assurance of safety and effectiveness of a product, and to ensure that the rights and welfare of study subjects are protected. This presentation will outline FDA regulations applicable to IVD device studies for investigational products, including those related to human subject protection, discuss information relevant to studies conducted during the development of a new product and explain the roles and responsibilities of study participants and data considerations that ultimately affect the quality of a premarket submission.

 

Tonya Wilbon B.S., M.S. (ASCP)—Overview of the Quality System regulation for Medical Devices
The Quality System regulation requirements govern the methods used in, and the facilities and controls used for the design, manufacture, packaging, labeling, storage, installation and servicing of devices intended for human use. These requirements are found in Title 21, Code of Federal Regulations, Part 820 (21 CFR 820) and are intended to ensure that medical devices will be safe and effective and in compliance with the Federal Food, Drug, and Cosmetic Act (the act); the methods used in, and facilities and controls used for the manufacture, pre-production design validation, packing, storage, and installation of a device must conform to the current good manufacturing practice (CGMP) requirements. Manufacturers are required to develop a quality system commensurate with the risk presented by the device, the complexity of the device and manufacturing processes, and the size and complexity of the manufacturing facility. The regulation identifies the essential elements that a quality system shall embody for design, production and installation of medical devices intended for human use. Of these elements, there are seven key quality indicators using the subsystem approach: design controls; management controls; production and process controls; corrective and preventive actions; equipment and facility controls; records, documents and change controls; and materials controls. Discussions between industry and the agency have determined that 4 major subsystems serve as the basic foundation of a firm’s quality system: design controls; management controls; production and process controls; and corrective and preventive action.

Sousan Altaie Ph.D.—Pre-IDEs
A pre-IDE focuses on how information will be gathered by the manufacturer to support the intended use and indications for use as proposed. Generally, when preparing a pre-IDE, a manufacturer provides administrative information, proposed intended use and indications for use, a brief description of the device/principle of operation, and a proposal or study protocol for method comparison or clinical study. The subsequent premarket notification (510(k)) contains results of those studies, as well as information on the analytical characterization and performance of the assay.  The pre-IDE process can be thought of as a “pre-submission” process. It may involve sending analytical or clinical protocols to FDA for review and comment before proceeding with studies. The process may also involve a meeting with FDA to discuss protocols and/or possible regulatory pathways. Pre-IDE submissions and meetings are strictly voluntary, and any comments or recommendations made in the review of protocols or during these meetings are not binding on the Agency or the Sponsor. A submission made under the pre-IDE process is not an official IDE application. In fact, most in vitro diagnostic devices (IVDs) are exempt from the medical device IDE regulations.  

It is appropriate to file a pre-IDE for a protocol review with the FDA when: (1) the new product involves cutting edge technology and it will be helpful to familiarize FDA with the technology in advance of the submission, (2) assistance is needed in defining possible regulatory pathways, (3) the studies involve complex data and/or statistical approaches and assistance is needed in defining appropriate analyses, and (4) the study designs are complex and you are seeking advice on ways to simplify and focus them on the studies needed to support your claim.

The purchase is $595 for the CD. Event materials are available on the CD itself. Each attendee is eligible for 0.3 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.