The FDA has issued a final rule that will require medical device premarket submissions to be sent in a single, electronic format. The change eliminates the need for paper and multiple copies. The new rule takes effect January 15, 2020.
According to the paper from the FDA published in the Federal Register, the action would “reduce the number of copies in electronic format required, thus improving and making more efficient the FDA’s premarket submission program for medical devices.” The final rule is expected to “produce cost savings for firms without imposing any additional regulatory burdens for submissions or affecting the Agency’s ability to review submissions.”
“We estimate that the final rule will result in annualized benefits of $1.76 million at a 3% discount rate and $1.76 million at a 7% discount rate, over 10 years,” according to the FDA paper. “We also estimate that the final rule will result in annualized costs of $0.75 million at a 3% discount rate and $0.87 million at a 7% discount rate, over 10 years.”
To read the FDA rule visit the Federal Register. Nonbinding recommendations are also available in an eCopy Program for Medical Device Submissions.