Compliance
Regulatory Status
As a medical device manufacturer, Biolife complies with FDA’s Premarket Notification process to obtain clearance for the use of our products. Specifically, Biolife has received clearance through three 510(k)s – K070520, K080210 and K130324 – for use to stop minor external bleeding from wounds and medical procedures, and for expanded application to include use for controlling moderate to severe external bleeding wounds.
All Biolife products are comprised of a powder with two main ingredients: potassium ferrate and a hydrophilic polymer. StatSeal devices for the healthcare industry are available in both powder and disc form; the disc is made of compressed powder that is encased in a white medical-grade foam. WoundSeal devices for the consumer and occupational health industries are available in powder form. Both powder and disc devices have passed all required safety, toxicity, and biocompatibility testing.
As new healthcare indications emerge, Biolife prepares and submits additional 510(k) filings as required.
Regulations and Licensure
All Biolife powder and disc products are distributed in accordance with current US FDA Regulations. The powder and disc are a Health Canada Class II Medical Device (wound dressing, hydrophilic, for wound exudates absorption) and, therefore, require licenses for distribution. Biolife powder and disc products can be distributed in Europe as a Class IIa under Annex V and VII Rule 4.
Quality Management System
Biolife has established its Quality Management System (QMS) according to the standards and regulations of:
US Department of Health and Human Services, Food and Drug Quality System Regulation, Title 21 of the Code of Federal Registrations, Part 820
International Organization for Standardization (ISO) ISO 13485:2016
The Canadian Medical Device Regulations (SOR/98-282)
The Medical Device Directive, MDD 93/42/EEC, Annex V