FDA seeks input on software-as-a-med device regulation

fda

The U.S. Food and Drug Administration has released a draft document focused on the requirements for clinical evaluation of software-as-a-medical devices (SaMD).

It aims to “harmonize” U.S. policy with the guidance prepared by the International Medical Device Regulators Forum (IMDRF).

Manufacturers will be required to develop evidence to demonstrate the safety, effectiveness and performance of the SaMD, the guidance states, though it will not replace or conflict with premarket or postmarket regulatory requirements. FDA asks for comment on eight aspects of the guidance, according to an article in Regulatory Affairs Professionals Society.

Conference

2019 Drug Pricing and Reimbursement Stakeholder Summit

Given federal and state pricing requirements arising, press releases from industry leading pharma companies, and the new Drug Transparency Act, it is important to stay ahead of news headlines and anticipated requirements in order to hit company profit targets, maintain value to patients and promote strong, multi-beneficial relationships with manufacturers, providers, payers, and all other stakeholders within the pricing landscape. This conference will provide a platform to encourage a dialogue among such stakeholders in the pricing and reimbursement space so that they can receive a current state of the union regarding regulatory changes while providing actionable insights in anticipation of the future.

Those aspects include whether it adequately addresses the relevant clinical evaluation methods and processes needed for SaMDs, whether other types of SaMDs than those outlined in the document should be addressed and whether the policy would produce unintended consequences for existing regulated devices.

“This is really huge, much bigger than many people might appreciate,” Bradley Merrill Thompson, an attorney with Epstein Becker & Green, said in email to FierceHealthIT.

It would apply to a huge number of mobile apps, as well as stand-alone programs for PCs used in healthcare, Thompson said. Since clinical evaluation is typically the most expensive part of product development for them, the requirements will have a significant impact on the cost and time to market involved in developing them.

IMDRF, which has no authority under U.S. law, created this guidance, not FDA, he points out.

And while it calls for collecting real-world evidence for validation, it’s not clear about when real-world evidence might replace premarket clinical study.

While the FDA does not regulate the practice of medicine, it might be inappropriate for it to set validation requirements for software that merely informs clinical decision-making in cases where the doctor remains in control of those decisions, according to Thompson.

Health IT Now, in a statement, said that FDA reviewers, health IT developers and the public can benefit from ongoing efforts to clarify health IT regulation.

“This announcement also serves as a reminder that more needs to be done here in the U.S. to create regulatory certainty for developers and the public,” it said.

Suggested Articles

Senate lawmakers released a draft package of legislation Thursday aimed at curbing health care costs they said they believe they can pass on a bipartisan basis…

What are some of the biggest challenges for independent medical practices?

Researchers at two universities plan to develop an autonomous trauma care system that uses robotics and artificial intelligence to treat soldiers.