Which of the agencys objectives are relevant to the activities or products being considered for cost recovery?
The regulation of IVD’s involves various pre-market regulation activities (regulations with which firms or products must comply before a product can be offered for sale) and post-market activities (regulations with which firms or products must comply after a product is available for sale) that involve monitoring compliance with regulations, investigation and enforcement. Pre-market approvals involve different regulatory processes based on the risk of the IVD to individuals and to public health. Class 1 represents the lowest risk group which permits administrative assessment and self-certification of conformity prior to market approval. Class 2 and 3 involve increasing risk levels and have additional requirements with products subject to application audits, conformity assessment and technical file reviews. Class 4 is the highest risk group and has additional requirements relating to design dossier examinations. Following approval, companies will be required to maintain certification of
Related Questions
- If a federal agency contracts with a private or other entity to conduct certain activities of the agency, does the Executive Order apply to the activities of the contractor?
- Under the guise of cost recovery, industry is actually paying to get their products approved. How can the government claim to be objective in its decisions?
- Do I have to include cost recovery activities in myMCERS data?
