FDA Makes Final Rule On Postmarketing Safety Reporting For Combination Products
By Jof Enriquez,
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The U.S. Food and Drug Administration (FDA) has issued the final rule describing the postmarketing safety reporting requirements for combination products, which comprise any two or three constituent parts — namely, a medical device and/or a drug and/or a biologic.
Because these components of a combination product each have unique reporting requirements and standards, which could result in inconsistent and incomplete postmarketing safety reporting by sponsors, FDA says the final rule will "ensure consistent, complete postmarketing safety reporting requirements for combination products that have received FDA marketing authorization, while avoiding duplicative reporting."
FDA says postmarketing safety includes manufacturing events, device malfunctions, and events causing injury to users, as well as the reporting requirements that relate to product and patient safety arising from these events.
The final rule requires combination product applicants to comply with postmarketing safety reporting requirements applicable to the product based on the application type (e.g., new drug application, premarket approval application, biologics license application), under which the combination product or constituent part received marketing authorization. In addition, they are required to submit additional specified reports based on the constituent parts included in the combination product.
Constituent part applicants (those with approved parts of the combination product) also are required to share certain postmarketing safety information they receive with one another.
The final rule specifies how both combination product and constituent part applicants must submit postmarketing safety reporting information to FDA, and what records they must maintain.
After reviewing 16 sets of comments on the proposed rule, FDA says it sought, through the final rule, to:
- clarify that the final rule applies only to combination product and constituent part applicants;
- clarify when a single report may suffice to comply with more than one reporting requirement; and
- incorporate biological product deviation reporting and device correction and removal reporting requirements applicable to combination product applicants.
First proposed in 2009, the issuance of the final rule is part of FDA’s efforts to ensure more consistent postmarketing safety reporting for these drug/device, biologic/device, biologic/drug or drug/biologic/device products, while enabling companies to be as efficient as possible with their reporting, according to RAPS.
FDA officials earlier this month touted significant progress with the way the agency handles combination product reviews. The agency last year released draft guidance outlining current good manufacturing practice (cGMP) requirements for combination products, which FDA says will be finalized soon. This year saw the issuance of draft guidance on human factors studies and clinical study considerations in combination product design and development, as well as final guidance on applying human factors and usability engineering to medical devices.
In August, FDA introduced a Pre-Request For Designation Process to assist sponsors when its unclear how their combination product should be classified. The agency expects the pilot phase of its new intercenter consult request (ICCR) process, designed to further streamline submissions and reviews of combination products, to be completed by the end of the second quarter next year.