Medical Devices

Announcing Two New Draft Guidances Regarding The Premarket Approval Process

On April 22, 2014, the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) issued two new Draft Guidance for Industry and Food and Drug Administration Staff.

1. The Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions
This draft guidance outlines FDA's proposal for a new, voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions and are subject to premarket approval applications (PMA).

Submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Docket Number:
FDA-2014-D-0363.

2. The Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval
This draft guidance clarifies FDA's current policy on balancing premarket and postmarket data collection during the Agency's review of premarket approval applications (PMA). Specifically, this guidance outlines how FDA considers the role of postmarket information in determining the appropriate type and amount of data that should be collected in the premarket setting to support premarket approval, while still meeting the statutory standard of safety and effectiveness.
 

Submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Docket Number:
FDA 2014-D-0090.

Thank you for your continued support,

Food and Drug Administration
Center for Devices and Radiological Health

Page Last Updated: 06/24/2014
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