Regulatory Status

As a medical device, 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, K130324 – for the treatment of minor external bleeding from wounds and medical procedure and for expanded application to include treatment for moderate to severe external bleeding wounds.

The powder has passed all required safety, toxicity and biocompatibility testing.

As new healthcare indications emerge, Biolife is preparing and submitting additional 510(k) filings as required.

Regulations and Licensure

Biolife’s powder products are distributed in accordance with current US FDA Regulations. The powder is a Health Canada Class II Medical Device (wound dressing, hydrophilic, for wound exudates absorption) and, therefore, requires licenses for distribution. Biolife powder 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 13485:2003

The Canadian Medical Device Regulations (SOR/98-282).

The Medical Device Directive, MDD 93/42/EEC, Annex I, Annex V and VII.

Below are Biolife’s CE certification, ISO Certification and Latex Free Declaration:

CE Certification

ISO Certification

Latex Free Declaration

The scope of the QMS is for the manufacture and distribution of topical hydrophilic dressings for temporary bleeding control associated with minor cuts, lacerations, skin tears, vascular access and surgical wounds. Biolife will comply with the most recent edition of the aforementioned documents and standards as well as new standards that the Company’s Quality / Regulatory Affairs departments deem appropriate. Biolife makes necessary revisions to its Quality Management System to ensure compliance with all applicable standards.

Biolife management conducts regular audits of the Quality Management System, with both inside and outside company support as required to assure it is performing in accordance with all regulations. These audits are both scheduled and/or ad-hoc as required to meet operational requirements and regulatory commitments.