CFR 21-803.19-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.19:Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
(a) We exempt the following persons from the adverse event reporting requirements in this part:
CFR 21-803.19-2014 history
2014CFR 21-803.19-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.19:Are there exemptions, variances, or alternative forms of adverse event reporting requirements?