Getting To Market With A

Medical Device

One of the most difficult aspects of getting a medical device to market is KNOWING WHERE TO BEGIN i.e., what are the steps for marketing and in what order they are to be taken. Essentially, medical devices are subject to the general controls of the Federal Food Drug & Cosmetic (FD&C) Act which are contained in the final procedural regulations in Title 21 Code of Federal Regulations Part 800-1200 (21 CFR Parts 800 - 1299). These controls are the baseline requirements that apply to all medical devices necessary for marketing, proper labeling and monitoring its performance once the device is on the market.

STEP ONE in the marketing process is to make absolutely sure that the product that you wish to market is a medical device, that is, does it meet the definition of a medical device in section 201(h) of the FD&C Act. For example, the product may be a drug or biological product that is regulated by a component in the FDA other than the Center for Devices and Radiological Health (CDRH) and for which there are different provisions in the FD&C Act. Or your product may be a medical device and is also an electronic radiation emitting product with additional requirements.

STEP TWO is to determine how FDA may classify your device - which one of the three classes the device may fall into. Unless exempt, FDA will classify your device. Classification identifies the level of regulatory control that is necessary to assure the safety and effectiveness of a medical device. Most importantly, the classification of the device will identify, unless exempt, the marketing process (either premarket notification [510(k)] or premarket approval (PMA)) the manufacturer must complete in order to obtain FDA clearance/approval for marketing.

STEP THREEis the development of data and/or information necessary to submit a marketing application, and to obtain FDA clearance to market. For some [510(k)] submissions and most PMA applications, clinical performance data is required to obtain clearance to market. In these cases, conduct of the trial must be done in accord with FDA's Investigational Device Exemption (IDE) regulation, in additon to marketing clearance.

Premarket Requirements: Labeling, Registration, Listing

Before marketing clearance is obtained the manufacturer must assure that the device is properly labeled in accordance with FDA's labeling regulations. Once clearance for marketing is obtained, the manufacturer must register their establishment and list the type of device they plan to market with the FDA. This registration and listing process is accomplished by the submission of FDA Form 2891 and 2892.

Postmarket Requirements: Quality System, Medical Device Reporting

Once on the market, there are postmarket surveillance controls with which a manufacturer must comply. These requirements include the Quality Systems (QS) (also known as Good Manufacturing Practices, GMPs) and Medical Device Reporting (MDR) regulations. The QS regulation is a quality assurance requirement that covers the design, packaging, labeling and manufacturing of a medical device. The MDR regulation is an adverse event reporting program.

In Vitro Diagnostic Devices      In vitro diagnostics (IVD)

IVDs are medical devices that analyze human body fluids, such as blood or urine, to provide information for the diagnosis, prevention, or treatment of a disease. The device classification for these devices can be found under 21 CFR 862, 21 CFR 864, and 21 CFR 866.

Clinical Laboratory Improvement Act (CLIA) of 1988

In addition to FDA regulation under the Food, Drug, and Cosmetic Act, in vitro diagnostic (IVD) devices are also subject to the Clinical Laboratory Improvement Amendments (CLIA) of 1988. This law established quality standards for laboratory testing and an accreditation program for clinical laboratories.

The requirements that apply vary according to the technical complexity in the testing process and risk of harm in reporting erroneous results. The regulations established three categories of testing on the basis of the complexity of the testing methodology: a) waived tests, b) tests of moderate complexity, and c) tests of high complexity. Laboratories performing moderate- or high-complexity testing or both must meet requirements for proficiency testing, patient test management, quality control, quality assurance, and personnel. These specific requirements do not apply to tests in the waived category.

In January 2000 the categorization of commercially marketed in vitro diagnostic tests under CLIA was tranferred from the Center for Disease Control (CDC) to FDA. CDRH's Office of Device Evaluation/Division of Clinical Laboratory Devices (DCLD) will determine the appropriate complexity categories for clinical laboratory devices as they evaluate premarket submissions. Waived products, devices exempt from premarket notification, and devices under premarket review by other FDA centers also will be processed by DCLD. Responsibilities currently assigned to CDC, including review of test systems, assays, or examinations not commercially marketed as IVD products, will remain with CDC.

Labeling

Specific labeling requirements for IVDs can be found under 21 CFR 809. Additional guidance can be found under "Device Advice Labeling Requirements for In Vitro Diagnostic Devices."

Product Complexity Database

FDA Database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm

CDC CLIA Test Complexity Files
http://www.phppo.cdc.gov/CLIA/testcat.asp

Links

FDA's CLIA homepage           

http://www.fda.gov/cdrh/clia/index.html

Product Complexity Database

            http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm

CDC CLIA Information

            http://www.phppo.cdc.gov/CLIA/default.asp

CDC   

http://www.cdc.gov/mmwr/preview/mmwrhtml/00016177.htm

Presentation: 510(k) Workshop: CLIA 2001

http://www.fda.gov/cdrh/present/042501_ivd.ppt
http://www.fda.gov/cdrh/present/042501_ivd.html
http://www.fda.gov/cdrh/present/042501_ivd.pdf

CLIA Waivers: List of Tests Waived by FDA

http://www.fda.gov/cdrh/clia/testswaived.html