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-Dr. Norman F. Estrin


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US FDA : The 510(k) - Part I

Let us first solve the mystery of its name.  The “510(k)” name simply comes from that section of the Federal Food, Drug and Cosmetic Act (FD&C Act).  Here is what Sec. 510(k) and Sec. 510(n) say:

Sec.510(k) Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use shall, at least ninety days before making such introduction or delivery, report to the Secretary (in such form and manner as the Secretary shall by regulation prescribe)

  1. the class in which the device is classified under section 513 or if such person determines that the device is not classified under such section, a statement of that determination and the basis for such person's determination that the device is or is not so classified, and 

  2. action taken by such person to comply with requirements under section 514 or 515which are applicable to the device.

Sec. 510(n) The Secretary shall review the report required in subsection (k) and make a determination under section 513(f)(l) not later than 90 days after receiving the report.

Laws, by their nature, only briefly describe the broad requirements.  In this case, subsequent laws also added to the requirements. Regulations were also proposed and finalized in the Code of Federal Regulations (CFR) in order to add more specific requirements.  For example, Sec. 510(k) only mentions that a person intending to introduce a device into the marker shall “report to the Secretary” but does not say anything about the nature of the report.  The “Secretary” is the Secretary of the Department of Health and Human Services.  The FDA Commissioner reports to the Secretary and is given the authority to develop necessary regulations.  (See Archives)

For medical devices, these regulations are developed in the Center for Devices and Radiological Health (CDRH). Some medical devices, such as in vitro diagnostics that help assure the safety  of the blood supply,  are regulated by the Center for Biologics Evaluation and Research (CBER) or jointly.  These Centers also help the manufacturers by publishing guidance documents to further explain the regulations.  Rather than try to decipher the specific language in the FD&C Act, we will move forward to discuss the overall requirements.

Premarket Notification

Section 510(k) of the FD&C Act requires anyone who intends to market a medical device in the United States intended for human use to submit a premarket notification (a “510(k)”) to the Agency at least 90 days before introducing the device onto the market (unless, of course, the device has been exempted from this requirement by the FDA).  This Premarket Notification is the “report to the Secretary” noted in the FD&C Act above.

THE PREDICATE DEVICE

The FDA will review the submission to determine whether the device is “substantially equivalent” (SE) to a device “legally marketed” in the United States that is not subject to premarket approval (PMA) requirements.  The overall purpose of the submission is to demonstrate to the FDA that the new device is as safe and effective as the legally marketed device to which it is being compared.  This is what we mean when we say that the new device is “substantially equivalent” to the “predicate device”.

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If you  have questions related to the contents of this column, please write to Dr Norman Estrin at yourFDAconsultant@medisourceasia.com and he will try to answer you.  This column is for you and we welcome your suggestions on how to improve it.  

Dr. Norman Estrin is a recognized authority in the medical device and cosmetic industries.  He has had over 30 years of experience in directing scientific and technical and regulatory programs in these industries.  He is Regulatory Affairs Certified (“RAC”) by the Regulatory Affairs Professional Society. Dr. Estrin is the founder of ESTRIN CONSULTING GROUP, INC. (ECG).  ECG offers cost-effective, experienced consulting to medical device firms on FDA- related issues.  Its Services include preparing 510(k) and other FDA submissions, regulatory strategy development    and acting as agent and official correspondent for non-U.S. medical device companies.

For more information, contact him at yourFDAconsultant@medisourceasia.com or visit his website: http://www.yourFDAconsultant.com