Industry Given More Time to Comment on Device Classification Rule
The FDA is extending the deadline for comments on a proposed rule on classification and reclassification of medical devices until Sept. 22, after stakeholders complained that the original June 23 deadline did not allow sufficient time to analyze and respond to the proposal.
The proposed rule would establish five categories of Class III devices, defined by risks, benefits and available controls. The FDA has said that the move could streamline classification of high-risk devices and promote consistent expectations about the process.
Under the planned rule, Class III devices would fall into one of the following categories:
- Devices that present known risks that can’t be controlled;
- Novel devices for which the risk-benefit profile is unknown or unfavorable;
- Devices for which general and special controls are insufficient, necessitating a full review of manufacturing information;
- Devices for which premarket review of any change affecting safety or effectiveness is required; and
- Combination products.
Interested parties may submit electronic comments to http://www.regulations.gov or written comments to Docket No. FDA-2013-N-1529. Read Thursday’s Federal Register notice here.The proposed rule is here. — Kellen Owings
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