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Compliance In Focus
Posted by John Lehmann on Fri, Jun 12, 2015

New House Bill Could Reduce 510(k) Submissions

On May 21st the House Energy and Commerce committee unanimously passed a bill that would allow New_House_Bill_Could_Reduce_510k_Submissionsmedical device companies to bypass 510(k) submissions for certain product modifications.  The 21st Century Cures bill will now move to the House floor, and bill sponsors hope for a vote by the end of the year.

The device “third-party quality system assessment section” was revised by the committee and would let companies make a device modification that would typically require a 30-day notice of a “special” PMS supplement could without a submission by having their quality system specially certified by a third-party auditor.

The new version passed by the full committee retains that language and adds certain modifications to the 510(k) cleared devices to the program.  This change could reduce the number of 510(k)s that companies need to submit. 

Modifications that would change the intended use of device or would alter the fundamental scientific technology of a device could not avoid a new 510(k) with a third-party quality system assessment.  However, modifications to 510(k) devices that do not meet those descriptions would qualify.

To qualify, a manufacturer would need to contract with a third-party auditing organization.  This was established in the 2002 “Accredited Persons” inspection program to audit its quality system, including design controls, relevant to pre-agreed-upon, “in-scope” devices.

In essence, if the auditor certifies the quality system, and FDA accepts the certification, the manufacturer will have a two-year renewable window of time in which it can make qualifying changes to in-scope devices without pre-market submissions to support it.

The impact of the 21st Century Cures Bill on 510(k) submissions is not clear, but it’s anticipated it will reduce submissions.  The FDA has not commented yet on the bill, but historically it has pushed back against these type of provisions citing the extra burden of training, accreditation of third-party auditors and a reduction of user fee revenue.

Representative John Shimkus, R-Ill, who authored the third-party quality assessment provision says it goal is “to ensure safety and innovation while reducing the FDAs workload in this area to free up resource form more complex reviews.”

What are your thoughts on the 21st Century Cures pending legislation?  If enacted, what will be the impact on 510(k) submissions?  Let know your thoughts.

IMARC University | IMARC Research

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Topics: FDA, 510(k), House of Representatives, 21st Century Cures Bill

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