FDA Medical Device Definition: A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.
FDA Leaded Apron Label Requirements and Exceptions
FDA Leaded Apron Import Information
FDA Leaded Apron Detentions (Leaded Apron Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Leaded Apron Manufacturers (Leaded Apron Suppliers)
- Leaded Apron Distributors
- Leaded Apron Processors
- Leaded Apron Repackers
- Leaded Apron Relabelers
- Leaded Apron Exporters
- Leaded Apron Importers
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U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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