Acquisition Regulatory Assessments: A Case Study

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Challenge

Investigating acquired products and associated FDA clearances.

A client took ownership of numerous products they had obtained through an acquisition. Remediation of the regulatory documents was needed, which included a review and evaluation of the 510(k) products to establish whether or not the current marketed products aligned with the existing FDA clearances. R&Q conducted a 510(k) inventory, which required a significant amount of investigation work to compile a list of all applicable products and associated 510(k) clearances, as well as non-filing justification (NFJ) with regard to design changes.

Solution

Working closely and understanding 510(k) intent.

During the inventory phase, a number of 510(k)'s were identified as being relevant to the acquisition. R&Q experts determined if the current marketed product aligned with the product cleared in the 510(k) or if the product had sufficient internal documentation to justify that design changes did not impact and an NFJ was accepted. FDA regulations and Guidance Documents, as well as internal client procedures and policies, were used to guide the decision making process. Remediation required interaction between regulatory and R&D, labeling, manufacturing, and marketing team members. Expansive work was done by R&Q to determine how to assess the clearances and to effectively work with teams to retrieve all necessary supporting information for the remediation.

Results

Effective regulatory assessment.

R&Q successfully assessed 45 510(k)s for regulatory acceptance. R&Q recommended that new 510(k)s were needed for seven systems, and identified 175 recommended action items. These included new Letters to File, updates to regulation data, new Medical Device Listings, R&D actions such as sterilization and cleaning validation, updates to packaging Bill of Materials, updates to labels, Operative Techniques, Instructions for Use, and more. In the end, regulatory data of the acquired products was documented and remediation plans were agreed upon.

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