A revised version of the 21st Century Cures Act, a bill being considered by the House Energy and Commerce (E&C) Committee, would allow medical device manufacturers to leverage third-party auditors to assess the state of their quality manufacturing systems.
The measure, contained within the "Medical Device Regulatory Process Improvements" section of the bill, was first introduced in the original draft of the 21st Century Cures Act, but was removed without explanation from the second draft of the bill.
Now legislators have re-added the measure to the 21st Century Cures Act—their effort to overhaul the way in which the US Food and Drug Administration (FDA) regulates products, among other efforts to bolster medical innovation.
Read our Regulatory Explainer on the 21st Century Cures Act here
A Third-Party System
Under the bill, FDA would be tasked with setting up a "third-party quality system assessment" program which would serve to accredit third-party assessors. Those third parties would then be tasked with inspecting certain medical device manufacturing operations to ensure they comply with 21 CFR 820—FDA's quality system regulation (QSR).
Only certain actions would be eligible for third-party inspection. Only "device-related changes" ordinarily subject to a 30-day notice, changes that would qualify for a Special PMA supplement or other minor device manufacturing changes are eligible.
Even once a company is assessed by a third party, the results of that assessment are still treated as "provisional" until 30 days after their submission to FDA. The agency may also extend its assessment for longer if it feels it needs more time to review the assessment. The results of the inspection would be valid for two years unless revoked by FDA.
Curiously, the legislation does not contain language to restrict the use of third-party audits to only manufacturers with no recent problems with their quality manufacturing systems.
The program is substantially similar to a pilot program already used by FDA's Center for Devices and Radiological Health (CDRH) known as the "Accredited Persons Program."
The appeal for medical device manufacturers is substantial. Third-party assessors could provide companies with a quick—though more expensive—way to have their facilities and products inspected for compliance. In theory, those inspections could pay for themselves by allowing a company to bring a modified product to market more quickly.
FDA is charged in the legislation to release guidance on third-party quality assessments within 12 months of the law's passage.
21st Century Cures Act, Subtitle M