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.
We have managed over 30 wound healing and wound related clinical studies, and supported over 60 related regulatory and quality assurance projects for a range of wound care and wound management indications, including:
- Honey-based dressings for chronic and acute wounds and burns – regulatory strategy, FDA pre-IDE, 510(k) preparation
- Tissue regeneration matrix for wound treatment – 510(k) preparation and general consulting
- Extracellular matrix based wound dressing – regulatory strategy, 510(k), quality system support
- Topical skin preparation to relieve various skin conditions – regulatory strategy, 510(k) preparation
- Bioresorbable fastener and insertion tool for wound closure – regulatory strategy, 510(k) preparation
- Anti-bacterial hemostatic sealant – clinical data management and statistical support
- Silver-based device coating technology – regulatory strategy, Device Master file preparation
- Living cell tissue regeneration for non-healing chronic wounds – clinical data management, statistics, safety and auditing
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.
Aptiv Solutions 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, we advised the company to change its regulatory strategy and lessen its product claims in order to gain 510(k) clearance. Aptiv Solutions prepared responses and directed several teleconferences with FDA personnel to negotiate microbiological associated claims and to address additional FDA concerns.
Within three months of our 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.