MVE and FDA Registration – FAQs

Blog March 26, 2025
Frequently asked questions about MVE and FDA registration
Frequently asked questions about MVE and FDA registration (Source: MVE Biological Solutions)

What does FDA registration mean and why is it important?

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 operates in compliance with FDA regulations and that its products are manufactured, labeled, and distributed according to the highest standards of quality and safety.

MVE Biological Solutions has officially registered all three of its manufacturing plants (located in Ball Ground, Georgia; New Prague, Minnesota; and Chengdu, China) with the FDA. Additionally, all current aluminum and stainless steel cryogenic storage tanks produced by MVE are listed with the FDA.

 

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

FDA registration: Indicates that a facility or product is registered with the FDA and meets regulatory requirements for operations and distribution. It does not involve FDA evaluation or testing. 

FDA clearance/approval: Applies to specific products, such as medical devices or drugs, which undergo stringent testing and evaluation by the FDA to confirm safety and efficacy before approval.

MVE’s FDA registration means they comply with current regulations, but it does not imply that the FDA has confirmed or approved their products.

What specific areas are checked for facilities registered with the FDA? 

  • Good manufacturing practices (GMP): Ensures products are consistently manufactured and controlled according to quality standards.
  • Good documentation practices (GDP): Maintains detailed records of production processes, testing, and product history.
  • Sanitation standards: Compliance with strict cleanliness and hygiene protocols.
  • Calibration and equipment maintenance: All machinery and tools are regularly calibrated and verified.
  • Personnel training: Staff must be trained to comply with FDA standards and procedures.
  • Design and manufacturing controls: Ensures medical devices meet safety, efficacy, and quality requirements. This includes design verification, risk management, quality control, and documentation throughout the product lifecycle as part of the FDA’s Quality System Regulations (QSR). 

What types of products are impacted by FDA registration? 

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

  • Cryogenic storage tanks for storing biological materials.
  • Accessories and components that come into contact with FDA-regulated materials (e.g., human cells, tissues, and biological products).

Does FDA registration affect how MVE produces its products?

FDA registration implies that MVE follows strict manufacturing processes, including: 

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

MVE consistently operates to the highest standards. We have been ISO 13485:2016 certified for many years. 

Note: ISO 13485:2016 is a voluntary standard that sets requirements for quality management systems (QMS) for companies that design and manufacture medical devices. This certification demonstrates that MVE’s products are safe and effective. The U.S. FDA currently adheres to ISO 13485 as part of the Quality Management System Regulations (QMSR).

How can customers verify MVE’s FDA registration? 

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

 

 Contact for more consultation on MVE cryogenic storage solutions:

 

References:

  1. MVE Biological Solutions. (n.d.). FDA compliance. https://mvebio.com/resources/fda/