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Antimicrobial Wound Dressing Market
Antimicrobial Wound Dressing Market Restraints
Challenges in classification of antimicrobial wound dressing into the FDA’s existing medical device classification is expected to create further complications in the marketing and gaining the regulatory product approval for antimicrobial wound products. In September 2016, U.S. Food and Drug Administration (FDA) assembled the advisory panel to receive recommendations regarding the appropriate regulatory classification for wound dressings containing drugs.
Antimicrobial wound dressings product are historically approved to market through the 510(k) process under product code FRO as unclassified and pre-amendments devices. Moreover, there are different opinions on whether classify antimicrobial wound dressings in Class II or Class III. However, medical device manufacturers will be affected with the FDA’s decision to regulate wound dressings containing drugs, as FDA’s Class II is appropriate for antimicrobial dressings and allows manufacturers to easily demonstrate their effectiveness and safety, while upregulating to Class III will makes manufacturers to undergo strict regulatory guidelines regarding higher safety and effectiveness of antimicrobial wound dressing to gain product approval. These change in the classification, could impact market players to increase the price of antimicrobial wound dressings, and may require larger time period to launch the product in the market, limiting the future growth of antimicrobial wound dressing market over the forecast period.