🏥FDA Notice on Information Collection for Medical Device Programs
Agency Information Collection Activities; Proposed Collection; Comment Request; Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools
Summary
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements associated with the Q-Submission and Early Payor Feedback Request Programs for medical devices and Qualification of Medical Device Development Tools.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The document outlines proposed information collection requirements related to medical device development feedback programs. This has financial implications for businesses involved in medical device submissions, as compliance with new requirements may impact operational costs and regulatory processes.