Every employee at ACell is committed to maintaining a comprehensive quality assurance program. At every level of our organization, we take pride in producing safe and effective products.
- All ACell products are marketed pursuant to 510(k) clearances issued by the U.S. Food and Drug Administration (FDA).
- All ACell products are manufactured in compliance with the regulations found at 21 CFR Part 820. Similarly, all ACell products are manufactured, stored, and distributed in compliance with all federal, state, and local requirements and accreditation standards.
- All manufacturing procedures are conducted under stringent controls and devices are assured free of Latex, Mercury, Bisphenol (BPA) and Diethylhexyl phthalate (DEHP).
- ACell’s manufacturing facilities are registered with the FDA and are ISO 13485 certified.
Questions regarding quality, safety, or performance of ACell products can be sent to QA@acell.com