Determining Classification or Designation

Several informative articles have recently been published regarding the classification or designation of CPs.55 The classification or designation of a CP should be undertaken as early as possible, because it is a requisite step in the development plan and regulatory strategy. The company must consult all applicable laws, regulations, guidance documents, agreements, and precedents. Classification or designation issues should also be discussed internally and/or with consultants before contacting the regulatory agency or submitting a request for classification or designation. In addition, the regulatory pathway of similar products should be considered when available. As more products are approved and the regulatory pathways become clearer, a classification or designation request to the regulatory agency will no longer be needed, although a submission should be considered if the product has unique characteristics. Discussions concerning the designation of a product in accordance with 21 CFR Part 32(e) need to account for the implications of that decision on the regulatory pathway. The designation of the product should not be decided prematurely, because the consequences of all pontential regulatory pathways need to be weighed and considered, such as Orphan Drug designation, premarket notification (501(k)), Quality System Regulation (QRS)6 vs current Good Manufacturing Practice7 (cGMP), and reimbursement issues. For example, a drug-device CP with a single premarket approval application (PMA) that is

Table 1

Combination Products: Regulatory Requirements and Directives

Country

Regulatory requirements

Definition

United States

European Union

Canada

Federal Food, Drug and Cosmetic (FD&C) Act, Section 201 [321]

Intercenter Agreements

The Council of European Communities. Council Directives 93/42/EEC (Medical Device Directive [MDD] ), 90/385/ EEC (Active Implantable Medical Device Directive [AIMDD] ) and 2001/83/EEC (Medicinal Products Directive [MPD]) as amended.

Medical Devices Guidance Document MEDDEV 2. 1/3, rev 2

Drug/Medical Device Combination Products Policy

Drugs, devices, and biological products are defined individually within the (FD&C) Act. Prior to 1991, the relatively small number of combination products (CPs) were regulated on an ad hoc basis.

A CP is comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity or when packaged separately, are CPs through labeling for use with the other component.

The Intercenter Agreements are working agreements developed between the Food and Drug Administration (FDA) Centers (i.e.. Biologies/ Drugs/Devices, Drugs/Biologies), which outline certain categories of products and how these products have been regulated by the FDA.

Drugs and biological products are defined individually within Council Directive 2001/83/EEC. Devices are defined individually within Council Directives 93/42/EEC and 90/385/EEC.

A CP is regulated either by the MDD/AIMDD or MPD. This guidance document provides the criteria for demarcation between MPD and MDD/AIMDD.

Drugs, devices, and biological products are defined individually within the Foods and Drugs Act. Before 1999, drug-device CP had to fulfill the requirements of both the Food and Drug regulations and the Medical Device regulations.

A CP is a product that combines a drug and a device component, such that the distinctive nature of the drug component and device component is integrated in a singular product.

regulated as a medical device would not be entitled to an orphan drug designation,5 even though the Orphan Drug Act applies to both drugs and devices. Orphan drug designation5 applies to products regulated as drugs or biologics via a new drug application (NDA) or product license application, whereas products regulated as medical devices via a PMA or 510(k) submission may apply for humanitarian use device9 status. Orphan drug designation does not apply to the device component but could be a major advantage for the drug component and ultimately the CP. Incorrect classification can lead to wasted time and resources, refusal of an orphan drug designation, and ultimately delayed approvals resulting in increased time to market, making subsequent rounds of financing more difficult.

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