MVE and FDA Registration – FAQs

What does FDA registration mean?

FDA registration means that a facility and/or its products have been officially registered with the U.S. Food and Drug Administration (FDA). This registration indicates that the facility complies with FDA regulations and that products are manufactured, labeled, and distributed according to the highest quality and safety standards.

MVE Biological Solutions has officially registered all three of its manufacturing facilities (located in Ball Ground, Georgia; New Prague, Minnesota; and Chengdu, China) with the U.S. FDA. Additionally, all applicable MVE-manufactured cryogenic freezers and dewars are now listed with the FDA.

How does “FDA-Registered” differ from “FDA Clearance & Approval?”

  • FDA Registration: Indicates that a facility or products are listed with the FDA and meet regulatory requirements for operation and distribution. It does not involve FDA evaluation or testing.
  • FDA Clearance/Approval: Applies to specific products, such as medical devices or drugs, that undergo rigorous testing and review by the FDA to confirm safety and efficacy before approval.

MVE’s FDA registration indicates our compliance with applicable regulations but does not imply product clearance or approval.

What specific areas are inspected for FDA-registered facilities?

FDA-Registered facilities must comply with:

  • Good Manufacturing Practices (GMP): Ensuring products are consistently produced and controlled according to quality standards.
  • Record-Keeping (Good Documentation Process): Maintaining detailed records of manufacturing processes, inspections, and product history.
  • Sanitation Standards: Adhering to strict hygiene and cleanliness protocols.
  • Equipment Calibration & Maintenance: All machinery and tools are regularly calibrated and validated.
  • Personnel Training: Employees must be trained to follow FDA standards and procedures.
  • Design and Manufacturing Controls: Demonstrates that medical devices meet regulatory safety, effectiveness, and quality requirements. They include design validation, risk management, quality control, and documentation throughout the product lifecycle as part of the FDA’s Quality System Regulation (QSR).

Why is FDA registration important?

FDA registration indicates that MVE’s facilities and products comply with applicable federal regulations designed to protect public health.

What types of products are affected by FDA registration?

FDA registration applies to products that are used in industries regulated by the FDA, such as:

  • Cryogenic storage devices used for biological materials.
  • Accessories and components that encounter materials subject to FDA oversight (e.g., human cells, tissues, and biologics).

Does FDA registration affect how MVE products are made?

FDA registration implies that we follow stringent manufacturing processes, including:

  • Using validated and calibrated equipment.
  • Maintaining meticulous production and testing records.
  • Conducting regular quality audits and inspections.

MVE has always operated to the highest standards. We have been ISO 13485 Certified for many years.

Note: ISO 13485 is a voluntary standard establishing quality management system (QMS) requirements for companies that design and manufacture medical devices. This ISO certification demonstrates that the products we manufacture are safe and effective. The US Food and Drug Administration (FDA) now follows ISO 13485 as part of its Quality Management System Regulation (QMSR)

How can customers verify MVE’s FDA registration?

Customers can verify FDA registration by contacting us via email or by searching the FDA’s public registration database at https://www.accessdata.fda.gov/

QUESTIONS: Please contact us if you still have questions regarding our return policy.

Americas
Customer Service: +1-844-683-2796
customerservice.usa@mvebio.com
breeders.cs@mvebio.com

EMEA
Customer Service: +44 7718 488236
customerservice.europe@mvebio.com
breeders.europe@mvebio.com

Asia Pac-Rim
Customer Service: +01 404-383-1900
csasia@mvebio.com

China (Domestic)
Customer Service: +86 28 6572 9660
Jessy Yang – Direct: +86 28 6572 9668
customerservice.china@mvebio.com

Australia & New Zealand
Customer Service: +01 404-383-1900
MVE.Australia@mvebio.com