Claire H. Topp

On January 7,
2019, FDA Commissioner Scott Gottlieb announced
significant updates to the FDA’s pilot Software Pre-Certification Program,
sometimes referred to more broadly as a Digital Health Pre-Certification
Program (“Pre-Cert”).

Pre-Cert was originally
announced in 2017 as part of the FDA’s Digital
Health Innovation Action Plan. The FDA envisions the program as a
streamlined process for bringing digital health technologies to market. More
specifically, the FDA hopes to develop Pre-Cert into a program by which certain
digital health developers can become precertified as part of an “Excellence
Appraisal.” Excellence-appraised developers could then take advantage of
streamlined premarket submission processes for their digital devices. To date,
the FDA has been working with a variety of stakeholders, including nine
companies “represent[ing] a wide range of companies and technology
in the digital health sector,” in developing the program.

In connection with the announcement earlier this week, the FDA issued “three documents that, together, launch us into the next phase of the agency’s vision of Pre-Cert.”

The first of
the three documents is a Regulatory
Framework for Conducting the Pilot Program within Current Authorities
(the “Framework”). This document builds out the regulatory framework within
which the FDA will implement Pre-Cert.  Here
are some highlights:

• At
  least to start, Pre-Cert is limited to software as a medical device (“SaMD”),
  defined as software intended to be used for one or more medical purposes that
  perform these purposes without being part of a hardware medical device. The FDA
  hopes eventually to expand the program to review all medical device software
  products, including software in a medical device (“SiMD”) and other software
  that could be considered accessories to hardware medical devices.

• The
  FDA intends to utilize the De Novo classification process (section 513(f)(2) of
  the FD&C Act), an existing pathway for certain new types of low to moderate
  risk devices to obtain marketing authorization as a Class I or Class II device
  as opposed to automatic Class III designation, for the next phase of Pre-Cert. Here
  is an overview of the proposed process:

• Participants
  with a SaMD product may participate in an Excellence Appraisal, as well as an
  optional Review Determination Pre-Submission. When submitting a product for De
  Novo Review, an excellence-appraised developer would submit a streamlined
  “Pre-Cert De Novo Request,” in which it would not need to re-submit information
  reviewed during the Excellence Appraisal or the optional Pre-Submission. Assuming
  premarket requirements are met, the FDA would classify the device by written
  order and, if the device is Class II, establish special controls, which may
  include Excellence Appraisal elements and postmarket data collection elements.

• Following
  a De Novo order, an excellence-appraised developer would also be able to take
  advantage of a streamlined “Pre-Cert 510(k)” process, in which the developer
  can again leverage submission requirements already documented during the
  Excellence Appraisal and optional Pre-Submission process. The FDA expects
  review of a Pre-Cert 510(k) to be more efficient than the review of a
  traditional 510(k). The Pre-Cert 510(k) can also be used for modifications to
  devices, assuming
  a 510(k) is required for the modification. 

The second
document is a 2019
Test Plan (the “Test Plan”). The Test Plan lays out the scope and
approach of the Pre-Cert pilot in 2019.  The
primary purpose of the Test Plan “is to assess whether the Excellence Appraisal
and Streamlined Review components together produce an equivalent basis for
determining reasonable assurance of safety and effectiveness for a SaMD product…
as compared to the traditional paradigm.” Here are some highlights:

• Consistent
  with the Framework, the scope of the Test Plan is limited to: (i) selected SaMD
  with De Novo Requests, and (ii) selected 510(k) submissions, which would be
  tested as if they were follow-on 510(k)s for devices classified through a
  Pre-Cert De Novo Request.

• The
  FDA plans to prioritize selection of submissions that will enable evaluation
  and testing of all four components (Excellence Appraisal, Review Pathway
  Determination, Streamlined Review, and Real-World Performance plan) outlined in
  the Working Model (discussed below), and to focus on cases representing a broad
  spectrum of software developers (e.g., small and large firms, low- and
  high-risk products, companies not traditionally considered medical device
  manufacturers).

• During
  the Test Plan, the FDA will apply both the proposed Pre-Cert pathway and
  the traditional review process to each test case, enabling it to refine
  Pre-Cert and confirm the validity of the overall program. Developers
  participating in the Pre-Cert pilot, after an Excellence Appraisal and optional
  Pre-Submission, will still need to submit full traditional marketing
  submissions. Internally, the FDA will then create a “mock Streamlined Review
  package” and review the submission on parallel paths, traditional and “mock
  Streamlined.” Similarly, the FDA will also be internally conducting
  retrospective tests of SaMD regulatory submissions previously reviewed.

Finally, the
third document released is an updated Working
Model (currently v1.0). The Working Model, which has been updated
over time with continuous public input, describes in greater detail the goal,
vision, scope, and process for Pre-Cert. It also includes summaries of public
comments that have been received and FDA responses to them.

Pre-Cert, if
implemented and successful in accomplishing FDA’s stated goals, could have a
significant impact on the healthcare industry beyond the software developers it
promises to impact directly. Digital health is increasingly becoming an
important tool for healthcare businesses. Streamlining processes for bringing
digital health technology to market and modifying existing technology will in
turn increase the rate at which providers are able to utilize updated digital
health technologies in practice. As this technology continues to garner the
focus and support of regulatory bodies, it will be important not only for
developers to understand the FDA’s streamlined approval process, but also for
providers to prepare for the potential transformative effect digital health
tools can have on the care they provide.

---