The final rule does not impose a federal mandate, as defined by title II of the act, on either state, local, or tribal governments or the private sector of $100 million or more in any one year.
The final rule does not impose a federal mandate, as defined by title II of the act, on either state, local, or tribal governments or the private sector of $100 million.
To ease the regulatory burden, the FDA has extended the effective date of the rule to June 1, 1997, and will not take regulatory action for an additional year on the design control requirement.