Yes, the federal code states who must comply with the regulations: “Modification of a certified product. The modification of a laser product, previously certified under 1010.2, by any person engaged in the business of manufacturing, assembling, or modifying laser products shall be construed as manufacturing under the act if the modification affects any aspect of[…]
Perform a GAP analysis and execute the plan in order to for the product/process to become compliant and safe. Once the compliance and risk engineering is completed and the documentation reflects current status of the product/process, a product report needs to be filed with the FDA/CDRH- preferably before introduction into commerce.
Specific type, application, and function are up to product designers, as long as it meets the regulations and standards. Non-defeatable (those interlocks designed not to be defeated) are typically used where there is a large and frequent potential for exposure such aas operator panels and doors. Defeatable interlocks (those that are designed to be defeated)[…]
A defeatable interlock device is one which is designed, by the manufacturer, to be defeated. Examples of defeat elements can include a “pull to activate” feature, an “interrupt key”, or a coded magnet (in the case of proximity-type magnetically activated interlock switches). Jamming a foreign object, taping, clamping an interlock may “defeat” its operation, but[…]