MDCI: Guiding Innovation

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Wound Care/Wound Healing Medical Devices

The aging of the population and a constant demand for products that speed healing and improve outcomes drives the wound care and wound healing industry. With burn and skin ulcer injuries on the rise, and millions of surgeries worldwide requiring trauma care, it is not surprising that wound care is an important and growing area for medical devices.

MDCI has assisted clients with a range of innovative and exciting wound care and wound healing products, including:

• Bioengineered wound healing products
• Interactive wound dressings
• Vitamin / Silver / Collagen and antimicrobial impregnated wound products

Wound Care and Healing Case Study

A worldwide manufacturer and marketer of wound care products developed a new wound dressing that contained a novel additive that had not been approved via a New Drug Application (NDA) or any other FDA submission. Although the company had submitted a 510(k) for this new dressing and was in process of responding to FDA questions, they needed additional expertise and guidance to help them more fully understand the FDA’s 510(k) requirements and to support them in the negotiation of labeling claims on this new product.

MDCI assumed responsibility as the FDA contact on behalf of the client, and negotiated claims to support the additive in product. After a critical review of the company’s original 510(k), microbiological test data, and subsequent responses, MDCI advised the company to change its regulatory strategy and lessen its product claims in order to gain 510(k) clearance. MDCI prepared responses and directed several teleconferences with FDA personnel to negotiate microbiological associated claims and to address additional FDA concerns.

Within three months of MDCI’s involvement, the new device received 510(k) clearance and is now successfully being marketed for the management of a variety of wounds, including diabetic foot ulcers, leg ulcers, pressure ulcers, first and second degree partial thickness burns, and surgical wounds.

Contact us for more information about wound care and wound healing device approval.