What is the purpose of the Drop Ball Certificate form?
The Drop Ball Certificate form serves as a declaration that specific articles, typically lenses, have been tested for impact resistance. According to regulations stated in 21 CFR 801.410, this certification assures that the items meet the necessary safety standards. It’s essential for manufacturers to guarantee the safety and reliability of their products, especially when they are subject to consumer scrutiny.
Who is required to complete the Drop Ball Certificate form?
This form must be completed by the manufacturer or a responsible party within the organization. An authorized individual must attest that the tested items comply with the specified regulations. This person holds the responsibility for ensuring that the testing has been adequately executed and documented.
What kind of testing is required for the certification?
The testing involves subjecting the lenses to a drop ball test, where an object is dropped from a specified height to assess its impact resistance. It's important to note that while the lenses may be labeled as impact resistant, they are not completely unbreakable or shatterproof. The testing procedures must align with the requirements outlined in 21 CFR 801.410.
How long is the record of testing maintained?
Records of the testing must be maintained for a minimum of three years from the date when the product is shipped. This retention is crucial as it ensures the availability of information should the FDA or other regulatory bodies request it for verification of compliance.
Is there a requirement to provide copies of the certificate?
Yes, copies of the Drop Ball Certificate and testing records must be made available upon request by the FDA. It's a part of regulatory compliance, and maintaining these records can help streamline any inquiries from oversight bodies.
What information is required to be filled out on the form?
The form requires several key details to ensure proper identification of the manufacturer and the specific products tested. This includes the company name, address, city, state, country, and ZIP code. Additionally, the name of the authorized individual, their signature, title, Federal Express AWB number, and the date of completion must be provided.
Can companies face penalties for failing to complete this form?
Yes, failing to complete the Drop Ball Certificate form or not maintaining the necessary records can lead to regulatory repercussions. Companies may face fines, product recalls, or other enforcement actions by the FDA. Therefore, it is imperative to adhere strictly to these requirements.
What should be done if there is a concern regarding the impact resistance of lenses?
If there are concerns about the impact resistance of the lenses, it is crucial to conduct additional testing and reassess the products before they are shipped. Document any findings and address them promptly. Open communication with regulatory authorities can also provide guidance on the next steps to take and ensure compliance with safety standards.