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  1. FDA In Brief

FDA In Brief: FDA reinforces postmarketing safety reporting requirements for combination medical products

For Immediate Release: Mar. 20, 2018

Media Inquiries

  Stephanie Caccomo

"We’re taking steps to strengthen and modernize our postmarket safety reporting requirements for combination products. Today we are issuing guidance to manufacturers on how they can provide more complete and relevant information related to combination products. We want to make sure that the process for submitting safety information to the FDA is clear, efficient and promotes timely evaluation of potential safety issues,” said FDA Commissioner Scott Gottlieb, M.D.

The draft guidance issued today explains when a single, complete report can be used to meet multiple reporting requirements and what the requirements are for sharing safety information with co-applicants of a combination product. Combination products, like continuous glucose monitors combined with insulins pumps to act as an artificial pancreas for patients, present significant opportunities for innovation and improvement in patient care. Today’s action will help sponsors comply with important FDA regulations on postmarketing safety reporting for these products process."

Today, the FDA released two guidance documents regarding postmarketing safety reporting requirements (PMSR) for combination products. Combination products are products composed of two or more different types of medical products (drug, device and/or biological product).

Both of these guidances address key elements of the 2016 final rule on PMSR for combination products.

The first, a draft guidance titled, “Postmarketing Safety Reporting for Combination Products,” addresses how companies can comply with the PMSR final rule. Although the PMSR regulations for drugs, devices and biological products share many similarities, each set of regulations establishes distinct reporting requirements, standards and timeframes. The guidance provides clarity on how to meet the PMSR requirements under the final rule, including streamlining opportunities, to ensure consistent, timely and complete reporting of adverse events, while avoiding unnecessary duplication. For example, under certain circumstances, manufacturers may submit a single report to satisfy multiple reporting requirements and submission timelines. The guidance also clarifies when and how co-applicants of combination products must share safety information about a combination product with one another under the PMSR final rule.

The second is an immediately-in-effect guidance titled, “Compliance Policy for Combination Product Postmarketing Safety Reporting,” which outlines the FDA’s compliance policy for the PMSR final rule. The guidance is immediately in effect in order to quickly communicate the new compliance policy given the upcoming compliance deadlines for certain provisions of the PMSR final rule and the amount of time needed for companies to prepare for them. Although this guidance is immediately in effect, the FDA will review all comments received and revise the guidance as appropriate. The guidance notes that the FDA does not intend to enforce certain requirements under the PMSR final rule for a period of time to ensure that combination product applicants have sufficient time to update reporting and recordkeeping systems and procedures, including their information technology systems, to comply with the PMSR final rule, and in doing so, have sufficient time to consider the recommendations and technical specifications that the FDA intends to provide through the final version of the “Postmarketing Safety Reporting for Combination Products” guidance after considering the comments on the draft guidance.

Together, these policies will provide industry with greater clarity about the FDA’s postmarket expectations for combination products. The FDA welcomes comments from stakeholders regarding its recommendations for implementing these important postmarketing safety reporting requirements.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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