📋FDA Notice on Information Collection for Electronic Products
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products
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 extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requirements for reporting and recordkeeping, general and specific requirements, and the availability of sample electronic products for manufacturers and distributors of electronic products.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The document outlines compliance and regulatory requirements related to the FDA's collection of information from manufacturers and distributors of electronic products. Business executives must ensure adherence to the FDA guidelines, as noncompliance could lead to penalties. The emphasis on recordkeeping and reporting signifies a heightened regulatory burden that could impact operational costs.