The article was written and posted by Mrs. Neethu Anto, Sr. Consultant – FDA Regulation. (Email: na@i3cglobal.com)
Automated Blood Cell Separator with Product Code ORG required 510(k) submission but under CBER.
The Centre for Biologics Evaluation and Research (CBER) regulates the medical devices involved in the collection, processing, testing, manufacture, and administration of licensed blood, blood components, and cellular products.
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The approval process and the related information can get from the below link:
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/510k-process-cber
These special controls along with the general controls should provide reasonable assurance of the safety and effectiveness of the device. Special controls, when combined with general controls, ordinarily address the risks associated with the use of the device.
For currently marketed products not approved under the premarket approval (PMA) process, the manufacturer should file with FDA for three consecutive years an annual report on the anniversary date of the device reclassification from class III to class II, or, on the anniversary date of 510(k) clearance.
A manufacturer that intends to market a device of this generic type should :
(1) conform to the general controls of the Federal Food, Drug, and Cosmetic Act, including the premarket notification requirements described in Title 21 Code of Federal Regulations (CFR), Part 807, Subpart E
(2) address the specific risks to health associated with the automated blood cell separator device identified in this guidance, and
(3) obtain a substantial equivalence determination from FDA prior to marketing the device (see also 21 CFR 807.85).
| Classification Name | Platelet and Plasma Separator For Bone Graft Handling |
| Regulation Description | Automated blood cell separator. |
| Definition | Preparation of autologous platelet-rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.
May include centrifuge, filters, tubes, syringes, and needles |
| Technical Method | Uses centrifugal and/or filtration methods to separate the whole blood into components, after which the platelet-rich plasma is withdrawn. |
| Regulation No. | 864.9245 |
| Product Code | ORG |
| Device Class | 2 |
| Submission Type | 510(k)
CBER |
| special control | Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.” |
| Predicate device | Contact us. |
| Sterility | Sterile |
| Non-Clinical Test | 1. Sterilization verification
2. Shelf life |
| Clinical Data | Not Required |
| Remarks
Additional requirements |
Contact Us.
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