Breakthrough Devices Program: Draft Guidance to Implement 21st Century Cures

On October 25, 2017, FDA published a draft guidance that describes FDA’s proposed approach to implement the Breakthrough Devices Program (“BDP” or the “Program”), a voluntary program to expedite access to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 Interested persons may submit comments to the draft guidance within 60 days of publication (December 24, 2017).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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FDA Releases Digital Health Innovation Action Plan and Initiates Software Pre-Certification Pilot Program

In two new posts on the Covington Digital Health blog we analyze the Digital Health Innovation Action Plan recently released by FDA and the agency’s new software pre-certification (Pre-Cert) pilot program.

The Digital Health Innovation Action Plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and processes and modernizing [the agency’s] tools so that they match the needs of digital health technology, and providing clarity on those policies and processes so that manufacturers and developers know what they need to do.”  The action plan includes three action items: (1) issuing new guidance regarding the regulation of digital health, (2) developing new regulatory approaches to oversight of digital health, including a new Pre-Cert program, and (3) building expertise on digital health within the agency.

The Pre-Cert pilot program is the agency’s first step in developing the Pre-Cert program.  Under the Pre-Cert program, FDA intends to pre-certify software developers who demonstrate sufficient quality performance.  Pre-certified software developers would be able to market their software devices with no, or streamlined, premarket review.  The goal of the pilot is to leverage input from the participating companies to help the agency establish the appropriate criteria for pre-certification and appropriate review process for pre-certified companies.

FDA Announces a New Digital Health Innovation Plan

FDA Commissioner Scott Gottlieb, M.D. recently announced the agency’s Digital Health Innovation Plan (the “Plan”)—a new agency-wide initiative to foster “innovation at the intersection of medicine and digital health technology.”  Dr. Gottlieb provided an overview of the components of the Plan, which include: (1) guidance documents implementing the digital health provisions of the 21st Century Cures Act; (2) guidance documents on low-risk digital health products; (3) a third-party certification pilot program; and (4) use of real-world evidence to support the development of digital health products.  While the Commissioner previewed the new Plan, he explained that details of each component would be forthcoming.  The Plan appears to align with the approach previously advanced by the Center for Devices and Radiological Health (CDRH) regarding digital health. Continue Reading