Devices

Stakeholders Want CDS Guidance Clarified

David McFarland

— 2 min read
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Several stakeholders are asking FDA to clarify its revised draft guidance on clinical and patient decision support software (CDS). AdvaMed says it is encouraged that the guidance uses a risk-based framework as called for by the 21st Century Cures Act and welcomes the use of several items from the International Medical Device Regulators Forum’s risk categorization framework for software as a medical device. But, it says, “with these additions, the draft guidance creates a more complicated process to evaluate a product’s regulatory status. As a result, we recommend that FDA include a flowchart or some other visual aid to assist the reader in understanding the regulatory status of a particular product.” The association includes specific recommendations and comments.

The Duke-Margolis Center for Health Policy comment says the center appreciates the challenges inherent in creating an effective risk-based strategy for regulating a broad category of medical devices and congratulates the agency on updating the draft guidance to help innovators in the field understand current FDA authority and describe CDRH’s regulatory approach to CDS software functions. The letter lists areas where the center believes additional clarification is needed.

Akin Gump commends FDA for “making significant strides toward clarifying its regulatory oversight of software functions that provide clinical decision support. The revised draft guidance offers much-needed clarifications on meeting the statutory CDS exemption and previews a risk-based framework for regulating the full range of CDS-related software tools…. Many of the statutory CDS criteria will require further clarification to enable the industry to confidently proceed and therefore merit further explanation.” The law firm also notes that FDA adoption of the International Medical Device Regulators Forum framework introduces new terminology and factors for evaluating risk that are novel to the Federal Food, Drug, and Cosmetic Act (FFDCA) and FDA regulations, and lack a regulatory underpinning. It asks for clarity in several aspects of FDA’s proposed CDS policies and offers considerations the firm believes will advance the agency’s goals and facilitate stakeholder understanding of FDA’s approach to CDS.

Pharmaceutical Research and Manufacturers of America says it also supports a risk-based approach to regulating CDS software functions. It asks that FDA: 

  •          apply the same regulatory framework for CDS associated with prescription drugs, regardless of the developer or disseminator;
  •          align its interpretation of non-device CDS with the statutory criteria in the FFDCA;
  •          continue its policy of exercising enforcement discretion for low-risk software functions; and
  •          clarify examples of functions on which FDA intends to focus its regulatory oversight.

The Medical Imaging & Technology Alliance calls for a flowchart to help readers understand what key elements to consider when assessing whether software as a medical device is a non-device CDS. It recommends further clarification in other areas of the guidance as well.

Finally, the American Medical Association strongly urges the agency to affirmatively address a number of issues the association has raised previously in response to FDA’s work on software as a medical device, including establishing standard terminology and definitions and reconsidering the use of the International Medical Device Regulators Forum risk framework.

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