The meaning of "FDA Registered" for biological cryogenic nitrogen tanks

Blog July 23, 2025

 The FDA has stringent quality requirements for products that wish to verify their quality. MVE’s FDA-registered biological cryogenic nitrogen tanks are designed to offer stable quality, minimize the risk of malfunctions, and ensure a safe storage environment for clinical biological samples.

FDA registered is especially important for cryogenic nitrogen tanks used in healthcare

“FDA Registered” ensures quality control for biomedical devices

Being “FDA Registered” means the manufacturer and their products are officially registered with the U.S. Food and Drug Administration (FDA). This Registration confirms that the manufacturing facility complies with FDA regulations, and the products (including cryogenic nitrogen storage tanks) are manufactured, labeled, and distributed by the highest quality and safety standards. In other words, FDA-registered biomedical equipment must meet strict quality management requirements throughout production. Specifically, FDA-registered facilities, such as MVE Biological Solutions, must comply with Good Manufacturing Practices (GMP) and the FDA’s medical device quality system regulations (21 CFR Part 820). This includes establishing manufacturing processes, conducting quality testing, maintaining proper documentation, keeping accurate production batch records, regularly calibrating equipment, cleaning facilities, and training staff by FDA standards. Design controls are also applied to ensure that the medical device remains safe and effective throughout its lifecycle. As a result, FDA-registered biological cryogenic nitrogen tanks will have stable quality, minimize the risk of malfunctions, and ensure safe storage environments for clinical biological samples. For sample storage equipment (like cryogenic nitrogen tanks), FDA registration is especially critical in healthcare. It demonstrates the manufacturer’s commitment to adhering to federal standards for public health protection. In the field of clinical sample storage, such as blood, tissue, stem cells, and IVF embryos, the reliability of the equipment is crucial. An FDA-registered cryogenic nitrogen tank ensures that the product is manufactured under regulatory oversight, providing laboratories, biobanks, and medical centers with peace of mind when using it for medical purposes. MVE Biological Solutions is the only manufacturer of deep cold storage equipment to hold an FDA registration, offering freezing solutions that meet the highest regulatory standards and ensure the safety of customers’ valuable biological samples.

Differentiating “FDA Registered” from “FDA Approved” and 510(k) Clearance.

The term “FDA Registered” is distinct from “FDA Approved” or “510(k) cleared” (510(k) clearance). FDA registration indicates that a company or product has been registered and listed in the FDA’s database, meeting the legal requirements for marketing; however, it does not imply that the FDA has reviewed or certified the safety/efficacy of that product. According to the FDA, when a facility registers and lists its device, “the entry in the FDA’s registration database is not an approval, clearance, or authorization by FDA for that facility or device.” In other words, the FDA does not “approve” the Registration—it is simply a process to inform the FDA of the facility and the types of devices it produces.  Conversely, “FDA Approved” applies to products that require FDA pre-market review and approval, typically drugs or high-risk medical devices (Class III). An FDA-approved device has undergone rigorous clinical testing, and the FDA confirms its safety and efficacy before it is approved for market release. 510(k) clearance is the process by which the FDA grants “substantial equivalence” for moderate-risk devices (Class II) – the manufacturer must prove that the new device is as safe and effective as a previously approved device (predicate device). Only after the FDA reviews the 510(k) filing and issues a clearance letter can the product be considered “FDA-cleared.” In the case of cryogenic nitrogen tanks for sample storage, these devices are typically considered to have low or moderate risk (e.g., tissue/cell storage devices), and in many cases, they are exempt from the 510(k) requirement. Therefore, FDA Registration and listing are sufficient to legalize the product for sale. MVE Biological Solutions affirms that FDA registration signifies compliance with regulations but does not imply that their products have been “approved” or “certified” through pre-market review. In summary, FDA Registration primarily concerns compliance with production processes and quality, whereas FDA Clearance/FDA Approval involves the FDA’s direct assessment of the device before it is released to the market.

MVE’s FDA Registered cryogenic nitrogen tanks

Illustration of an MVE cryogenic nitrogen freezer (MVE Series) used for the cryopreservation of biological samples in laboratories.

MVE CryoSystem Series – Compact, economical aluminum nitrogen tanks for laboratories

MVE CryoSystem Series – Compact, economical aluminum nitrogen tanks for laboratories

MVE’s cryogenic devices are widely used in biobanks, IVF centers, clinical laboratories, and hospitals to store cells, tissues, plasma, and embryos at ultra-low temperatures. After being registered with the FDA, all of MVE’s cryogenic freezers and nitrogen storage tanks have been officially listed in the FDA’s medical device database, meaning they meet stringent quality management requirements (e.g., complying with GMP and 21 CFR Part 820) during production. Below are some of the MVE cryogenic nitrogen tank and freezer product lines now FDA registered, serving for human sample storage in medicine, IVF, diagnostics, and biobanking:

  • MVE HEco™ Series. 
  • MVE CryoSystem Series. 
  • MVE Stock Series. 
  • MVE SC & XC Series. 
  • MVE Vapor Shipper Series. 
  • MVE Doble Series. 
  • MVE Blood Bag Shippers. 

These devices have been registered by MVE and listed with the FDA in 2025. Being listed in the FDA database confirms that, from design to production and final inspection, these cryogenic nitrogen tanks comply with the strict quality standards of the medical industry. For applications in human sample storage (cells, tissues, blood, embryos) for diagnostics, treatment, or reproductive assistance, this “FDA Registered” certification ensures product quality, giving end-users (clinical labs, IVF centers, biobanks) more confidence in using equipment directly related to human health. With the assurance of being “FDA Registered,” MVE Biological Solutions’ cryogenic nitrogen tanks guarantee safe and effective biological sample storage solutions. Contact Biogroup experts today for more detailed advice on the product.  Contact information:

Learn more about MVE Biological Solutions’ cell storage products

References

  1. FDA. (n.d.). The difference between device registration and approval. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov
  2. MVE Biological Solutions. (n.d.). Information on regulatory compliance and FDA-registered cryogenic product catalog. Retrieved from https://www.mvebio.com
  3. Cryoport Inc. (n.d.). Cryogenic products registered with the FDA. Retrieved from https://www.ir.cryoportinc.com
  4. MVE Biological Solutions. (n.d.). Cryogenic product lines and applications in biomedicine. Retrieved from https://www.mvebio.com