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FDA Issues Draft Guidances With New Regulatory Pathway Options for PMA Products

NSF Health Sciences

In April 2014, the FDA released draft guidance documents for premarket approval, Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval (PMA) and Expedited Access for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These draft guidance documents reflect the agency's continued steps towards facilitating a more timely market introduction of PMA products, while still meeting the statutory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.

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