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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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The RACB is the governing body of the RAC program and consists of a minimum of seven members, including: the RACB chairman, the chairman of each examination committee, at least one member holding an RAC who does not serve on an examination committee, and one public member who does not hold the RAC designation.
The public representative will be selected from experienced regulatory professionals, senior-level officials in organizations involved with healthcare products or the general public. The public representative must have an understanding of the healthcare product sector, the role of the regulatory profession and an understanding of professional credentialing.
RACB members are appointed to a three-year term of service and are eligible for appointment to a second term. Members may not serve more than two consecutive terms on the RACB. Total consecutive years of service on the RACB or any examination committee should not exceed nine years.
A committee will be established for each examination developed and administered under the RAC program. Examination committees report to the RACB.
Examination committees typically consist of 8– 10 members, with a balance of expertise among the major product types, product lifecycle and regulatory roles.
Examination committee members are appointed to a three-year term of service and are eligible fora second term. Examination committee members may not serve more than two consecutive terms on an examination committee.
Individuals may not concurrently serve on more than one examination committee.
Committee members should be RAC credentialed and are expected to maintain the RAC while serving on the examination committee.
An ex-RAC examination committee member will not be permitted to take the RAC examination for three years after completion of service.
The RAC Program Office resides in space within the RAPS headquarters, with access to full operational services available at RAPS. Staff support for the RAC program is provided by qualified RAPS employees. The RAPS executive director serves as executive director of the RAC program and works directly with the RACB, its committees and vendors. RAPS also will provide staff support for finance and general administration, vendor management, customer service, marketing, and technology services and support. Staff supporting the RAC program will be accountable to the executive director and will record actual time allocated to RAC program activities.
The executive director will review staff requirements and issues with the RAPS affiliate Board chairman.
The RAC fiscal year will be 1 January to 31 December. Operational plans for the RAC program will be developed by the RAC program staff, working in consultation with the RAPS affiliate board, RACB chairman, examination committee chairman and vendors.
The RAPS Affiliate Board will have approval on RAC budgets. The RACB will provide advisory input when necessary. The RAC budget will be included as a distinct component of the overall RAPS budget.
RAC finances will be managed by the RAPS finance staff, reviewed by the RAPS accountants. Monthly financial statements will be prepared and reviewed by the RAC program staff.