BIO Comments on Prescription Drug-Use-Related Software
April 29, 2019
BIO submitted comments on the Food and Drug Administration’s (FDA) open docket on Prescription Drug-Use-Related Software.
In the comments, BIO says it’s important to encourage innovation and ensure developers are aware of regulatory pathways available for bringing novel technologies to the health care and medical markets. There’s currently insufficient clarity about the regulatory pathway and jurisdiction of drug-use-related software technology.
However, BIO also expresses concern about FDA’s intent to regulate beyond the accepted confines of “labeling,” which has been recognized by the industry and reinforced by the courts. Elements of the framework could stifle innovation. BIO urges FDA to more specifically outline the types of communications it intends to regulate, how review will be coordinated across FDA Centers, and how the framework will interact with other guidance, among other issues.
Download Full Comments Below
BIO Comments Prescription Drug Use Related Software FDA–2018-N-3017
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BIO submitted comments on the Food and Drug Administration’s (FDA) open docket on Prescription Drug-Use-Related Software.
In the comments, BIO says it’s important to encourage innovation and ensure developers are aware of regulatory pathways available for bringing novel technologies to the health care and medical markets. There’s currently insufficient clarity about the regulatory pathway and jurisdiction of drug-use-related software technology.
However, BIO also expresses concern about FDA’s intent to regulate beyond the accepted confines of “labeling,” which has been recognized by the industry and reinforced by the courts. Elements of the framework could stifle innovation. BIO urges FDA to more specifically outline the types of communications it intends to regulate, how review will be coordinated across FDA Centers, and how the framework will interact with other guidance, among other issues.