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Contact:
Wanda Moebius
202-434-7240
wmoebius@advamed.org
June 12, 2013

New White Paper Affirms FDA's 510(k) Change Guidance

Only Targeted Improvements Needed

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) today released a new white paper recommending that current FDA guidance for determining when to submit a 510(k) for a change to a currently marketed medical device be maintained with some targeted modifications, arguing the current process works well to ensure the safety and effectiveness of devices.

The white paper includes a comprehensive analysis of the key laws and regulations, as well as previous guidance and other relevant documents, associated with the 510(k) process and FDA’s quality systems regulation (QSR).

The document concludes that FDA’s current guidance on 510(k) modifications, issued in 1997, in combination with the QSR “continues to afford both the Agency and industry a strong foundation” for deciding when a new 510(k) is needed for a change to a legally marketed device.

“The agency’s current guidance on 510(k) modifications has a more than 15-year track record of providing clear direction for companies and FDA reviewers on when a change warrants a new 510(k),” said Janet Trunzo, senior executive vice president, technology and regulatory affairs, AdvaMed.  “The white paper underscores the strength of the current process, which affords American patients timely access to new medical technology innovations.”

While supportive of the current FDA guidance, the white paper includes several recommendations to further strengthen it.  AdvaMed recommends that the current guidance be modified to require that:

  • Manufacturers evaluate any change made to a specification, method or procedure in accordance with an established procedure to evaluate the need for a new submission;
  • Manufacturers leverage existing quality system procedures that ensure changes to the device design are reviewed, validated, verified as appropriate, and approved; and
  • Decisions related to “significantly affecting safety and effectiveness” be based on the results of validation (or verification testing when applicable) undertaken in compliance with the QSR.

A copy of the AdvaMed white paper can be found here.

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments.  AdvaMed members range from the largest to the smallest medical technology innovators and companies.