Regulation of Wound Management Products

The passage below is from the MedMarket Diligence Report #S247, “Worldwide Wound Management, 2008-2017: Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World.”

In the USA, medical devices fall within one of three categories depending on the complexity of the product and the invasiveness of its application. Fabric dressings are simple and minimally invasive, and to are designated as Class I devices, whereas products containing biomaterials of human or animal origin are in Class III. Some products that may be considered as examples of “Advanced Wound Care” (AWC, an abbreviation that is used widely in this report, and is synonymous with “advanced wound management”) are classified as Class II.

Medical devices require an investigational device exemption for clinical evaluation in humans; they are regulated through and receive 510(k) approval through a pre-market approval scheme regulated by the FDA in the USA, and are approved through the CE Marking process which was introduced in the early 1990s in Europe. 

Class I devices in Europe require development and manufacture to be performed under international standard quality control systems, and device dossiers to be managed by the manufacturing company. Class II devices require the dossiers to be submitted for review, and Class III devices require a more substantial device dossier to be compiled and submitted for review with more rigorous toxicological and clinical evaluation. In Europe, devices which incorporate biological materials derived from animals are classed automatically as Class III devices.

In the USA, pharmacological developments (with a pharmacologically active therapeutic benefit) automatically require an investigational new drug (IND) application. Biologic materials are reviewed for a biologics license application (BLA) through an IND by the CBER division of the FDA (CBER stands for Center for Biologic Evaluation and Research).

General wound care products generally fall within the Class I or Class II device categories around the world; any products containing mammalian proteins are Class III devices. The route for approval of more sophisticated products, like those designed to deliver an active therapeutic endpoint, such as pharmaceuticals and tissue engineering products, is more complex and less consistent in different regions around the world.

A wide range of regulatory approval conditions are applied to cell-based therapy products. Many of the technical challenges associated with creating a new tissue-engineered product are focused on the clinical proof phase, the regulatory requirements associated with making, proving effectiveness and safety of the product, and a number of controls on product claims and usage. Often the approach to achieving regulatory approval seems to be arduous, inconsistent and arbitrary. This is best illustrated by the complexity of approval for new tissue engineered products that exist today.

Autologous products for skin are currently available in the USA and new approaches to offering these cells wrapped up in customized services are becoming prevalent around the world. Allogeneic cell-based products for treatment of burn victims, skin conditions, and chronic wound care are now approved from a small number of suppliers in the USA, and several more on their way around the world.

Autologous tissue and cells transplanted during surgery do not have any regulatory requirements placed upon them by the US FDA. However, the devices used to carry out the surgical procedure are regulated as Class I medical devices. These products are required to be manufactured under Good Manufacturing Practices; they are regulated as Devices, and require 510(k)s in the USA. In Europe they are Class I medical devices.

Donated cadaveric tissue products produced to aid surgical construction must be manufactured under Good Manufacturing Practices (GMP) with ATSB or FDA approved manufacturing in the USA, and require Pre-Market Application (PMA) in the USA if extensively processed between removal from donor and transplantation to recipient. These products are classified as Medical Devices. They require extensive infectious disease screening and testing, with procedures which closely control good handling practices.  They require pre-market approval as they represent a substantial risk due to risk of spreading infectious agents. These products fall under the Center for Biologic Evaluation and Research (CBER) in the USA, and are classified in Europe as Class III devices requiring a substantial and reviewed device dossier, as they contain biologically derived materials. Minimally manipulated products do not require a PMA. A number of companies such as LifeCell sell products in this category, and a number of other companies are developing products in this area.

Tissue engineered implants represent a broad category of materials from those that are substantially donated allogeneic tissue with cells removed, to those products that are completely biologically based such as follicle and placental cell infusions.

Synthetic products are Class II devices, requiring PMA approval and good manufacturing practices in the USA, and the equivalent CE Mark and Class II approval in Europe.

Biologically-derived products are approved through the mutual recognition process in Europe as biological pharmaceuticals and require PMA approval in the USA, and manufacture to good manufacturing practice standards. These products are regulated by the CBER in the USA as biologics requiring a Biologics License Application.

See the complete report description, table of contents and list of exhibits at link.