FDA Publishes Draft Guidance on Investigational IVDs Used in Therapeutic Product Clinical Trials

On December 18, 2017, FDA announced the availability of a new draft guidance, titled “Investigational IVDs Used in Clinical Investigations of Therapeutic Products.”  The draft guidance is intended to inform both product sponsors and IRBs regarding the application of the Investigational Device Exemption (IDE) regulation to investigational in vitro diagnostic devices (IVDs) used in therapeutic product clinical trials.  The guidance expands on elements of the agency’s July 2016 draft guidance document for product sponsors, titled “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product,” which we addressed in a previous blog post.

With the growing focus on personalized medicine, IVDs are increasingly used in clinical investigations of therapeutic products to guide the management of subjects in such investigations, for example, to select or classify subjects, assign subjects to therapeutic product arms or doses, or monitor responses to treatment.  FDA stated that it was issuing the new draft guidance because the agency is concerned that sponsors and IRBs may not understand that the IVDs used in therapeutic product clinical trials are also often investigational and are subject to the IDE regulation in addition to the Investigational New Drug (IND) requirements applicable to the therapeutic product.  The guidance clarifies that an investigational IVD is subject to the IDE regulation even if the therapeutic product is exempt from the IND regulation and even if the manufacturer does not intend to seek FDA clearance or approval for commercial distribution of the IVD.

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FDA Issues Draft Guidances Outlining Digital Health and Decision Support Software Regulatory Approaches

FDA has described its evolving approach to regulating digital health and decision support software in two new draft guidance documents:  Clinical and Patient Decision Support Software and Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act.  These draft guidances announce the agency’s initial interpretation of the health software provisions enacted as part of last year’s 21st Century Cures Act and describe which digital health technologies FDA will regulate as “devices.”

Our alert discusses key takeaways from the draft guidances and implications for digital health technologies, including clinical decision support and patient decision support software, technologies that incorporate machine learning or AI, and digital health products marketed by pharmaceutical companies.

Here are a few noteworthy items from the draft guidance documents:

  • Under FDA’s initial interpretation of the Cures Act, many clinical decision support (CDS) software functions could remain subject to FDA regulation.
  • Dynamic digital health solutions, such as those that incorporate machine learning or artificial intelligence (AI), are not directly addressed in the drafts.
  • FDA has proposed an enforcement discretion approach for decision support software aimed at patients, even though patient decision software (PDS) was not addressed directly in the Cures Act.
  • Consistent with the Cures Act, many software functions that were previously subject to FDA enforcement discretion (i.e., not actively regulated as devices) no longer meet the definition of “device.”
  • Pharmaceutical companies should note that CDER joined one of the draft guidances, which states that FDA requirements beyond those outlined in the draft guidance may apply to digital health products disseminated by or on behalf of a drug sponsor.
  • FDA indicates that its regulatory oversight of CDS software that analyzes physiological signals to provide diagnostic, prognostic and predictive functionalities could include algorithms that analyze and interpret genomic variations to determine a patient’s risk for a particular disease.

As discussed in our alert, companies who are marketing or developing digital health products should assess how FDA’s proposed policies may impact their product portfolio and consider submitting comments on the draft guidances.  The FDA docket is open for comments until February 6, 2018.

Breakthrough Devices Program: Draft Guidance to Implement 21st Century Cures

On October 25, 2017, FDA published a draft guidance that describes FDA’s proposed approach to implement the Breakthrough Devices Program (“BDP” or the “Program”), a voluntary program to expedite access to medical devices intended for treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The BDP implements section 515B of the Federal Food, Drug, and Cosmetic Act (FDCA), as created by the 21st Century Cures Act. The Program focuses on reducing the time associated with the development, assessment, and review of eligible devices. Interested persons may submit comments to the draft guidance within 60 days of publication (December 24, 2017). Continue Reading

Letter to File or New 510(k)?: CDRH Finalizes Two Key Guidances

On October 25, 2017, FDA’s Center for Devices and Radiological Health (CDRH) issued two final guidance documents that provide FDA’s current thinking regarding whether a modification to a 510(k)-cleared device will require the submission of a new 510(k), or may be documented in a “letter to file” as part of the manufacturer’s quality system.  Such changes could include modifications to labeling, technology, or materials.  CDRH issued draft versions of these documents in August 2016.

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FDA Public Hearing on an Innovative Approach to Devices Referencing Drugs

In a new post on the Covington Digital Health blog, we analyze FDA’s proposed approach for device sponsors seeking to market devices referencing drugs (“DRDs”) when the drug sponsor does not wish to collaborate with the sponsor of the device.  FDA will hold a public hearing on November 16, 2017 to discuss DRDs.   To read the post, please click here.

Practical Considerations for Device Industry Policyholders Experiencing Puerto Rico Hurricane Losses

Last week, FDA released a statement about the challenges facing the medical device manufacturing industry in Puerto Rico in the wake of Hurricanes Irma and Maria. FDA is concerned that the damage to the island will lead to shortages of important medical products. The statement highlights that device manufacturers both inside and outside Puerto Rico may face serious supply-chain disruptions. These disruptions could result in substantial losses for device manufacturers.

Commercial property insurance policies typically provide a variety of coverages that may help protect policyholders from these losses. Most policyholders know that commercial property policies cover business-interruption losses resulting from physical damage to their covered property. But some may not appreciate that property insurance policies often also cover:

  • Losses resulting from damage to suppliers (or customers);
  • Losses resulting from damage to service providers (such as power and internet);
  • Losses resulting from an inability to access otherwise undamaged locations (for instance, increased transportation costs resulting from shut downs at ports or diesel fuel shortages); and
  • Losses resulting from government orders that prohibit access to insured locations.

A full discussion of the different coverages that policyholders should consider as potential sources of recovery, as well as practical tips for post-loss recovery, is available in our recent Covington alert, which may be accessed here.

FDA Finalizes Guidance on Medical Product Classification

On September 26, 2017, FDA announced in a Federal Register notice the availability of the final guidance document, Classification of Products as Drugs and Devices & Additional Product Classification Issues.  This guidance provides the Agency’s current thinking on approaches for classifying products as drugs and devices, and on certain additional product classification issues, such as the request for designation (RFD) process.  The guidance combines and finalizes two draft guidance documents from 2011:

  • Classification of Products as Drugs and Devices and Additional Product Classification Issues (available here), and
  • Interpretation of the Term “Chemical Action” in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (available here).

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FDA Draft Guidance Addresses Medical Device Status of Microneedling Products

On September 15, 2017, FDA published a draft guidance document titled “Regulatory Considerations for Microneedling Devices” (Draft Guidance). The Draft Guidance describes when a microneedling product is a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) and discusses the regulatory pathway for microneedling devices. Interested parties have 60 days, until November 14, to submit comments to FDA on the Draft Guidance.

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FDARA Reauthorizes Device User Fees and Amends Key Device Provisions of FDCA

Last month, President Trump signed the FDA Reauthorization Act of 2017 (FDARA).  FDARA reauthorizes the Medical Device User Fee Amendments (MDUFA), allowing FDA to collect medical device user fees for fiscal years 2018 to 2022 after FDA’s current user fee authority ends on September 30, 2017.  Notably, the reauthorized MDUFA adds a substantial new user fee for de novo classification requests.  FDARA also contains important substantive amendments to the FDCA, including provisions modifying FDA’s approach and procedures for device establishment inspections, clarifying the premarket review process for medical imaging devices intended to be used with an approved contrast agent, addressing the classification of accessory devices, and requiring FDA to report on servicing of devices.

A full summary of the device-related provisions of FDARA is available in our recent Covington alert.

FDA Finalizes Guidance on Interoperable Medical Devices

On September 6, 2017, FDA finalized a guidance document entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices” (“Final Guidance”).  In the Final Guidance, the agency outlines design considerations for manufacturers when developing interoperable medical devices, as well as recommendations about information to include in premarket submissions and device labeling.  Interoperability of devices can encourage the availability and sharing of information across systems, even when products from different manufacturers are used.  A draft of this guidance was issued on January 26, 2016.

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