EMERGO SUMMARY OF KEY POINTS:

• The US FDA is launching a new expedited registration route for breakthrough and innovative medical devices.
• The Breakthrough Devices Program covers qualifying 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE) and de novo applications.
• The program entails earlier interactions between regulators and manufacturers during product development.

The US Food and Drug Administration plans to establish a new market authorization pathway for innovative and breakthrough medical devices that would replace current priority review programs including the Expedited Access Pathway (EAP) and the Priority Review Program.

Mandated by the 21^st Century Cures Act, the Breakthrough Devices Program will incorporate elements from the EAP, Innovation Pathway and Priority Review Program to expedite development and regulatory review of cutting-edge devices targeting serious diseases and conditions.

The FDA draft guidance explains how the agency plans to implement the Breakthrough Devices Program, as well as some if its features intended to ease US market entry for qualifying devices.

Priority review for qualified FDA registrants

FDA premarket registration applicants that qualify for the Breakthrough Devices Program will undergo priority review, which entails moving to the front of the review queue and receiving additional review resources, according to the guidance. 

FDA notes, however, that although the new program is designed to expedite commercialization of breakthrough devices, the agency’s track record with previous priority review programs shows that review timeframes can sometimes take longer than for more conventional device registrations because of these products’ novel components. Instead, other features of the program including more interactive and earlier communication with registrants during their device development processes will help expedite market authorization of breakthrough devices, argues the agency.

“We believe that the Breakthrough Devices Program may enable patients to have more timely access to these devices than they would otherwise because of the earlier interaction between FDA and sponsors during the device development process,” states the guidance.

Additional features of the Breakthrough Devices Program

Other key elements of the new FDA expedited program include:

• Interactive and timely communication: Earlier and more interactive communication between the agency and registrants, including during applicants’ product development phases
• Pre- and post-market data collection: For breakthrough devices subject to PMA, FDA may consider the amount of post-market data to be collected on these devices in lieu of premarket data in their market authorization decisions
• More flexibility for clinical study designs: FDA may consider issues such as phased study design, pre-specified endpoints and other factors to ease sponsors’ clinical study design obligations
• Review team support: FDA review teams will be assigned to each breakthrough device premarket submission; staff that are experienced in “innovative approaches to regulatory science” will make up these review teams
• Expedited manufacturing inspections: Breakthrough device program registrants requiring pre-approval inspections for manufacturing and quality system compliance may undergo expedited review (including forgoing of such inspections) depending on their compliance track records

Criteria for program participation

In order to qualify for participation in the Breakthrough Devices Program, a device must meet the following requirements listed in the guidance:

• Device performs more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition
• Device incorporates breakthrough technologies
• No approved or cleared alternative device is currently marketed in the US
• Device provides significant advantages versus currently available alternative products

What does FDA consider a “breakthrough technology?”

One key criterion—whether a device utilizes breakthrough technology—begs the question, what is a breakthrough technology according to FDA?

In the guidance, the agency defines breakthrough technology as that which provides “the potential for a device to lead to a clinical improvement in the diagnosis, treatment…cure, mitigation or prevention of the life-threatening or irreversibly debilitating condition.”

Examples provided in the guidance include a transcatheter heart valve delivered transcutaneously, thereby obviating the need for open heart surgery; an internal hemostatic device to temporarily control bleeding; and gene signature tests providing prognostic data for cancer patients to help determine optimal treatment strategies.

Related US FDA regulatory services from Emergo:

• US FDA 510(k) consulting for medical device and IVD companies
• FDA Pre-Sub (Q-Sub) consulting for medical device companies
• Whitepaper: FDA regulations for novel and innovative medical devices
• Video overview: The FDA medical device regulatory process