Premarket Notification 510(k) Process for CBER-Regulated Products

Center for Biologics Evaluation and Research (CBER) regulates medical devices related to licensed blood and cellular products while applying appropriate medical device laws and regulations. The medical devices regulated by CBER are intimately associated with the blood collection and processing procedures as well as the cellular therapies regulated by CBER.

Jurisdiction of medical device review by the CBER is listed at Devices Regulated by the Center for Biologics Evaluation and Research | FDA

Please do not send CBER device applications to the Center for Devices and Radiological Health (CDRH). All CBER device applications must be submitted in accordance with the CBER Regulatory Submissions - Electronic and Paper website information.

What are 510(k)s?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device (section 513(i)(1)(A) FD&C Act). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims. A legally marketed device is a device that was legally marketed prior to May 28, 1976 (pre- amendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found SE through the 510(k) process, or a device that was granted marketing authorization via the De Novo classification process under section 513(f)(2) of the FD&C Act that is not exempt from premarket notification requirements. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate. Legally marketed also means that the predicate cannot be one that is in violation of the FD&C Act.

Until the submitter receives an order declaring a device SE, the submitter may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter.

Please note that FDA does not typically perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance.

Preparing a Premarket Submission

The FDA has developed several different types of resources to help you prepare a premarket submission. These include the following:

• CDRH Learn: A video-based series of teaching modules, seminars, and recorded webinars that cover a variety of policy and guidance efforts.
• FDA’s Q-Submission Program: Prospective applicants of future premarket submissions may request feedback from the FDA through a Pre-Submission, which is part of the Q-Submission Program. Information about this program may be found in the FDA guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. We encourage you to read our online information and other available resources prior to sending any request for feedback.
• FDA Breakthrough Devices Program: This voluntary program helps patients have more timely access to certain medical devices that treat or diagnose a life-threatening or irreversibly debilitating condition by speeding up their development, assessment, and review. Devices subject to Premarket Approval applications (PMAs), premarket notifications [510(k)], or De Novo classification requests may be eligible. Sponsors can send a Breakthrough Designation request for their device at any time prior to sending the device’s marketing submission.

Premarket Notification 510(k) Resources

• Overview on Premarket Notification 510(k)
  • What is Substantial Equivalence?
• Information on 510(k) Submission Process
  • How to Find and Effectively Use Predicate Devices
  • How to Prepare a Traditional 510(k)
  • How to Prepare a Special 510(k)
  • How to Prepare an Abbreviated 510(k)
  • Is a new 510(k) required for a modification to the device?
• FDA Forms

CBER Approved Products

• Substantially Equivalent 510(k) Device Information
• Premarket Approvals and Humanitarian Device Exemptions with Supporting Documents
• Evaluation of Automatic Class III Designation (De Novo) Summaries (CBER)
• Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
• Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases

Guidance Documents

• The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
• The Special 510(k) Program
• The Abbreviated 510(k) Program
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
• eCopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff
• Refuse to Accept Policy for 510(k)s
• User Fees and Refunds for Premarket Notification Submissions (510(k)s)
• Deciding When to Submit a 510(k) for a Change to an Existing Device
• Deciding When to Submit a 510(k) for a Software Change to an Existing Device

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Food and Drug Administration
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Silver Spring, MD 20993-0002

ocod@fda.hhs.gov

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