Guidance for Industry and FDA Staff: Expedited
Access for Premarket Approval and De Novo Medical Devices Intended
for Unmet Medical Need for Life-Threatening or Irreversibly
Debilitating Diseases or Conditions, April 13, 2015, Federal Register.
Effective April 15, 2015.
Guidance for Industry and FDA Staff: Balancing
Premarket and Postmarket Data Collection for Devices Subject to
Premarket Approval, April 13, 2015, Federal Register.
Guidance for Industry: Risk Evaluation and
Mitigation Strategies: Modifications and Revisions, April
7, 2015, Federal Register.
Comments are due June 8, 2015.
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