Included in the modifications are the addition, withdrawal, correction, and revision of certain consensus standards that will be recognized for use in premarket submissions and other regulatory requirements for medical devices. These changes will be added to the list of FDA Recognized Consensus Standards, and include the following:
The withdrawal of standards and their replacement by others, if applicable.
The correction of errors made by FDA in listing previously recognized standards.
The changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.
In addition, FDA lists modifications that are being made involving the addition of standards not previously recognized by the Agency, and provides a listing of new entries and consensus standards that are being added.
Do you manufacture a medical device or other FDA-regulated product? We can help ensure that your product is compliant with all of the Agency’s requirements. To learn more about our services and how we can help you, contact us today.
FDA Extends Comment Period For Its “Request for Quality Metrics” Draft Guidance
Last month, FDA published a draft guidance titled “Request for Quality Metrics,” which outlined the ways in which it intends to collect and use quality metrics. The guidance states that the data will...