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What’s Important in Assessing the Need for Additional 510(k) Clearance for Medical Device Changes?

Medical device companies often find themselves in a bind if the U.S. Food and Drug Administration (FDA) scrutinizes their decisions that product changes did not trigger the regulatory requirement for a new 510(k) submission for the changed device. They often use a thought process that is unacceptable to FDA. In other cases, they do not sufficiently document their rationale, even if the correct thought process is utilized.  Fairly simple steps can be taken to institute the correct thought process with appropriate documentation.

1. Establish a Standard Operating Procedure (SOP)

Device companies usually do a good job of establishing written SOPs to cover regulatory requirements under the Quality System Regulation (21 C.F.R. Part 820). However, many device firms neglect to establish SOPs to control compliance efforts in other FDA device regulatory areas, including 510(k)-related obligations.  An SOP that standardizes the regulatory thought process for product changes helps to assure more consistent decisions by the company’s regulatory affairs professionals.  It also serves as a basis for training relevant individuals in the decision-making process.  A 510(k) SOP should also be cross-referenced in other appropriate SOPs, e.g., an engineering change order SOP, to serve as a “trigger” to alert relevant company employees that the 510(k) decision-making process should be utilized in making product changes.  Device companies can sometimes overlook the need to assess the need for additional 510(k) clearance in pursuing product changes.

2.  Cross-Reference the Appropriate Materials in Your SOP

Citing to 21 C.F.R. Sec. 807.81(a)(3) in your SOP is a good start.  It’s the legal standard for when product changes do or do not require additional 510(k) clearance.  The problem is that this regulation is not specific enough to cover all of the potential fact scenarios. To account for this, FDA has issued a guidance document that further expands on the concepts found in Section 807.81(a)(3).  The guidance document  is entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device (510(k) Memorandum No. K97-1) (Jan. 10, 1997).   Firms should incorporate the guidance document into their 510(k) decision-making SOP and follow it. Doing so helps companies to align their internal thought process with FDA’s and to reduce the risk of future, and potentially expensive, compliance problems.  However, one most remember the guidance document is just that–a guide–and that it does not provide the answer to the product change question or address the device modification circumstances in every instance.  One needs to apply common sense and reason beyond the literal written questions and considerations of the guidance document in many cases to truly assess the need for additional 510(k) clearance.

3. Document Your Decision to the Fullest When Your Decision is Not to File a New 510(k)

Many times device companies will only “fill out” the relevant product change flowcharts attached to the guidance document.  The flowcharts address the general type of product change at issue as well as labeling, technology/design and materials changes.  While the flowcharts serve a purpose, they should not substitute for a well-written regulatory rationale, utilizing the relevant facts and the guidance document’s concepts, which explains in more detail the firm’s rationale for not filing a new 510(k) submission.  This allows a company to demonstrate that it went through a thorough, thoughtful and “good faith” process in reaching its decision, even if FDA disagrees.

The above steps can greatly improve a firm’s ability to identify, deliberate on, and document its 510(k) decision-making.  They also put a firm in a better position to defend its decisions in the face of FDA scrutiny if it later becomes necessary.

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