CLN - Regulatory Roundup

New Guidance Documents Clarify FDA’s Approach to Digital Health Technologies

Regulatory Roundup: November 2019

The Food and Drug Administration (FDA) has released a suite of guidance documents to encourage innovative digital health tools, while also ensuring that the agency’s regulatory approach advances along with these technologies. The first of these documents, the draft guidance Clinical Decision Support Software, is a revised draft guidance that incorporates feedback received on the previous draft published in 2017. The updated draft guidance clarifies which categories of clinical decision support software (CDS) would be subject to FDA oversight due to high risk of patient harm, which CDS categories would only be subject to enforcement discretion due to low risk of patient harm, and which CDS categories do not meet the definition of a medical device. FDA proposes specifically focusing its regulatory oversight on CDS that helps inform the clinical management of serious or critical conditions, but that does not provide information that would enable healthcare providers to independently evaluate the software’s recommendations.

FDA also issued the final guidance, Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act, which outlines the agency’s interpretation of the types of software that are no longer considered medical devices under the 21st Century Cures Act. Specifically, this guidance explains that certain digital health technologies (such as mobile apps that are intended only for maintaining or encouraging a healthy lifestyle) tend to pose a low risk to patients and therefore generally fall outside the scope of FDA’s regulation.

FDA Lays Out Framework for New Program That Could Streamline Premarket Review

The Food and Drug Administration (FDA) has issued draft guidance outlining the goals for and implementation of a new program called the Accreditation Scheme for Conformity Assessment (ASCA) Pilot, which aims to make premarket review for medical devices more consistent, predictable, and efficient. Under the ASCA Pilot, FDA-recognized accreditation bodies will accredit testing laboratories to assess whether medical devices conform to certain consensus standards. Manufacturers will then be able to work with these ASCA-accredited testing laboratories to evaluate their devices and will be able to include the results of these evaluations in premarket submissions. FDA believes that the ASCA Pilot could improve the premarket review process by reducing the need for certain steps, such as consultations with internal FDA experts about testing methods and determinations, review of complete test reports done by laboratories, and additional information requests.

FDA Clears Abbott’s High- Sensitivity Troponin Test

Abbott has received Food and Drug Administration clearance for the Architect STAT high-sensitivity troponin I blood test, which measures very low levels of troponin and is intended to help diagnose patients with suspected myocardial infarction within 2 to 4 hours of admission. The test runs on Abbott’s fully automated Architect analyzer, and its results are intended for use with other diagnostic information such as electrocardiogram results, clinical observations, and patient symptoms. The test is also designed so that it is not affected by interference from biotin, a popular over-the-counter supplement that can impact troponin test results. In conjunction with this clearance, Abbott will introduce the Heart Partnership Program, which will help hospital care teams to integrate this new test into their care pathways.

Exact Sciences Gets Expanded FDA Approval for At-Home Colon Cancer Screening Test

The Food and Drug Administration has approved Exact Sciences’ noninvasive colorectal cancer screening test, Cologuard, for average risk individuals ages 45 and older, expanding on the test’s previous indication for individuals ages 50 and older. This new indication aligns with the American Cancer Society’s (ACS) updated colorectal cancer screening guidelines, which call for screening to begin at age 45 instead of at age 50 as previously recommended. The ACS made this change in response to the rising incidence of colorectal cancer rates among American adults under the age of 50.

Cologuard is an at-home test that analyzes a person’s stool sample for 10 DNA markers, as well as for hemoglobin. The test has a specificity of 87%, and individuals should confirm positive results with a diagnostic colonoscopy.