Area of focus

Premarket Review

Our premarket review practice focuses on providing strategic advice from the earliest stages in the product development cycle in order to optimize the regulatory pathway. Leveraging the technical background of our lawyers and regulatory science professionals, we provide comprehensive regulatory assistance during all phases of the Food and Drug Administration (FDA) clearance or approval process.

We also assist clients in preparing all types of premarket submissions, including investigational device exemptions...

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Representative experience

Advocated FDA’s reclassification of a novel imaging device, tissue culture media products for ex vivo growth of human cells, and in vitro diagnostic test systems, avoiding the need for a PMA approval.

Although a client had received two non-approvable letters prior to our involvement, we assisted in the preparation of necessary PMA amendments and secured a unanimous Advisory Panel recommendation for approval.

To assist a client in expediting a product to market, we obtained the FDA’s designation of expedited review status for a novel orthopedic and women’s health device and negotiated favorable review timetables.

Though the FDA previously told our client that a device for diagnosing tubo-peritoneal infertility would require a PMA approval, we drafted a 510(k) notice that the agency cleared.

When other FDA counsel had concluded a device would require PMA approval, we assisted a small start-up client in obtaining clearance of a 510(k) notice without clinical data for a cardiac bypass device.

After FDA determined that existing clinical data did not demonstrate substantial equivalence, we met with FDA to explain the data, addressed the issues, and helped our client obtain a 510(k) clearance.

Advised and assisted a client seeking FDA regulatory marketing approval of its Retinal Prosthesis System.

Assisted a client in preparing an abbreviated 510(k) notice for a surgical mesh that demonstrated the device’s substantial equivalence. FDA cleared this within 60 days of its submission.

Assisted a foreign client in obtaining PMA approval for an extracorporeal device for removing cholesterol from the blood of certain types of patients with hypercholesterolemia.

Assisted companies on numerous cardiovascular device approvals, including left ventricular assist devices and artificial heart devices.

Managed the Advisory Panel process and helped secure a positive vote on the risk-benefit of the ResQCPR System, a CPR- assist device that increases likelihood of survival after cardiac arrest.

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