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FDA Issues Draft Guidances with new Regulatory Pathway Options for PMA Products

On April 23, 2014, FDA issued two complementary draft guidance documents related to
premarket approval applications: “Balancing Premarket and Postmarket Data Collection for
Devices Subject to Premarket Approval (PMA)” and “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly
Debilitating Diseases or Conditions.” These draft guidance documents reflect the agency’s
continued steps towards facilitating a more timely market introduction of PMA products, while
still meeting the statutory standard of reasonable safety and effectiveness. This memorandum
summarizes the key topics addressed in the guidance documents and the implications of these draft guidances on the medical device industry.