Staff Writer

WASHINGTON – Digital health took center stage at the Food and Drug Law Institute (FDLI) annual conference Thursday, with FDA Commissioner Scott Gottlieb acknowledging that while the agency has made strides in crafting a regulatory approach for this area, work remains.

"We've recognized that FDA's traditional approach to medical product regulation isn't always well suited to emerging technologies like digital health," Gottlieb acknowledged. However, he did highlight the agency's Digital Health Innovation Action Plan, which was unveiled last July. The plan provided information and timelines for the agency's approach toward digital health and implementation of the 21st Century Cures Act. (See BioWorld MedTech, July 28, 2017.) New initiatives included in the plan were the launch of the agency's digital health software pre-cert program, the issuance of new guidance, and an increase staff both in terms of numbers and expertise.

His comments on the planned areas of focus for each FDA center kicked off a two-day event that included a number of sessions on digital health and evolving regulatory pathways for medical devices.

"We're seeing digital health really becoming a true segment within the medical device ecosystem," said Zachary Rothstein, associate vice president of technology and regulatory affairs at the Advanced Medical Technology Association (AdvaMed), during a separate session.

He acknowledged that the FDA has added "significant regulatory certainty" to help bring these products to market, and at the same time venture capital funding is rebounding.

In his speech, Gottlieb also emphasized that the FDA was looking to provide more interaction with developers and grant expedited review to their devices, particularly if their products could offer enhanced safety over existing offerings.

"We also want to make it easier for medical device manufacturers to make comparative safety claims about their products," he said.

Going beyond devices, Gottlieb added that the FDA will look for ways to improve its approach regarding its field activities.

"As part of the 2019 budget, we're seeking resources to improve our forensic labs and expand certain inspectional work," he said.

In addition, the FDA plans to clarify its approach to the regulation of gene therapy. Gottlieb said the agency would develop "a comprehensive framework," to include guidance on manufacturing standards and approaches. The agency also is looking to give clinical guidance that describes development pathways and potential accelerated approval endpoints for products targeting specific disease areas, such as hemophilia.

Guidance is welcome

A panel that followed Gottlieb's remarks discussed the impact of increased guidance on industry. The discussion was framed by acknowledgement of the issuance of executive orders on rulemaking and the so-called "Brand Memo." In that memo, the Office of the Associate Attorney General issued a policy that prohibits the Department of Justice from using its civil enforcement authority to convert agency guidance documents into binding rules. Civil litigators are prohibited from using guidance documents – or noncompliance with guidance documents – to establish violations of law in affirmative civil enforcement actions.

"I don't see that impacting our issuing guidance," CDRH Director Jeffrey Shuren said when asked about the memo later in the day, noting that he was speaking personally and not on behalf of the agency.

Regarding devices specifically, Sandy Kalter, vice president and chief regulatory counsel at Medtronic, took a positive view of guidances.

"I don't think it's affecting the medical device industry all that much," she said.

She added that guidances lend some predictability, and although the number of documents that have come out over the past two years might prove "daunting," industry welcomes the help from the FDA. Of particular note were documents related to breakthrough devices and 510(k) alternate pathways. Her comments echoed those she made at the 2015 edition of the FDLI advertising and promotion conference, when she noted that she "prefer[s] the flexibility of guidance assuming that it goes final." (See BioWorld MedTech, Oct. 5, 2015.)


Training and retaining qualified staff long has been an issue within the FDA, particularly when the private sector offers more money and incentives. When asked what they would ask Congress to do if they could have one thing, Howard Sklamberg, partner at Akin Gump Strauss Hauer & Feld LLP said money for staffing to deal with complex regulatory issues and a method to streamline the federal hiring process. Staffing is especially important because science is progressing faster than the process, he said.

Kalter noted that the team-based approached proposed by CDRH could help in retaining good employees. A "super office," which Shuren discussed last year at MedTech 2017, would focus on the total product life cycle, combining the functions of the Office of Device Evaluation, the Office of Compliance, and the Office of Surveillance and Biometrics. (See BioWorld MedTech, Sept. 29, 2017.) It is hoped that staff would think of themselves as division and management teams. Shuren said CDRH staff will consequently think less in terms of branches and offices and more in terms of divisions and management teams. At the same event, Bill Maisel, the center's chief scientific officer, said they wanted "the lowest [possible] level in the organization to be able to make good decisions."

Another area of note was the agency's move to increase its enforcement presence in the international mail facilities. While Gottlieb noted that this interdiction work relates to foreign unapproved and counterfeit drugs, as well as controlled substances, shipped through the mail, Kalter said these efforts can extend to devices, too.

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