Pre-cert Program, or also known as the Software Precertification Pilot Program (Pre-Cert), was first mentioned in the FDA’s Digital Health Innovation Action Plan. The purpose of this pilot program is to create a foundation for digital health regulation that is able to rapidly respond to the constantly changing softwares.

Pre-Cert Program will allow certain SaMD (Software as a Medical Device) to be more readily accessible to patients by lessening the required processes, while guaranteeing safety and effectiveness.

To be eligible for the program, FDA states that, “Any organization that intends to develop or market software that meets the definition of device in section 201(h) of the FD&C Act in the United States would be considered in-scope for the Software Pre-Cert Program.

The FDA has received more than 100 applicants but has only chosen 9 companies to participate in the pilot program.
They are: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily.


Two Levels of Precertification:

– FDA wants to provide equal opportunities to large or small companies with different SaMD background experience.

They will do so by dividing the precertification into two levels and applying the appropriate standard to each applicant or company.

-> Level 1: Permits an organization, with no or limited experience in delivering software, to develop and market certain lower risk software without review.
They also must have:
– Organizational element and strategies to show that they can provide as well as maintain a safe, effective lower-risk SaMD (Software as a Medical Devices).
– A limited track record in developing, delivering, and maintaining product.

-> Level 2: Permits an organization, with an extensive experience in delivering software, to develop and market certain lower / moderate risk software without review.
They must also have:
– A level of assurance in developing a safe, effective lower / moderate riskSaMD
– A proven track record of developing, delivering, and maintaining products is required.

In addition, Level 2 Pre-Cert organizations will have to reasonably assure that they can:
– Understand the clinical use and patient environment, disease or condition complexities
– Identify and rapidly address unanticipated postmarket issues in the SaMD
– Apply postmarket lessons to iteratively improve the SaMD throughout the lifecycle processes.


TPLC Approach for SaMD

Last week’s article discussed how effective the TPLC approach can be in regulating softwares.
This week’s article will expand and provide more descriptive information about the TPLC approach as it is also a crucial part of the Pre-Cert program.

->The Total Product Lifecycle (TPLC) approach will be used as the basic guideline for the Software Pre-Cert program.  The TPLC approach of SaMD (Software as a Medical Device) focuses more on the organization, compared to the traditional TPLC approach which focuses on the medical device itself.

The TPLC approach will emphasize the manufacturer’s ability to:
1. Build trust that they have quality and organizational excellence
2. Be transparent of their organizational excellence and product performance throughout the entire TPLC of the product
3. Verify the SaMD’s performance, effectiveness and safety.

The Total Product Lifecycle Approach of Pre-Cert Program is composed of four different reviews.
These are:

Excellence Appraisal
Review Determination
Streamlined Review (if required)
Real-World Performance

Excellence Appraisal:  The FDA will determine specific objective criteria and methodology in order to precertify a company and also determine if they are capable of keeping the precertification status.

This component follows these development principles:
     1. Designed for organizations of all sizes
     2. Allows organizations to demonstrate excellence based on outcomes achieved by their unique processes, operations, and capabilities
     3. Applies least burdensome approach by observing organizations’ current processes
     4. Recognizes organizations following existing standards (e.g., Quality System Regulations, ISO 13485, ISO 12207, ISO 62304, ISO 14971, ISO 9001)5 and outcomes achieved by following those processes

Review Determination or Review Pathway Determination: This process provides a risk-based framework which pre-certified organizations can refer to and choose the best premarket review pathway for their products.

This process will:
 – Identify elements, methods, and process for pre-certified organizations to use in determining review pathway based on risk of the product (e.g., by a flow chart or a decision tree).
 – Develop a structured method for pre-certified organizations to inform the public, end users, and FDA about key elements of the SaMD, including a robust description.

Also, the IMDRF’s (International Medical Device Regulatory Forum)  SaMD risk categorization plays an important role in this process in understanding the risk-based framework.

(Figure 1 retrieved from International Medical Device Regulator Forum, IMDRF)

Other components of this sections include identifying product-level elements of SaMD and determining the SaMD risk.

Streamlined Review: this process will minimize the required process the SaMD will have to go through. The review will be comprised of understanding the product, premarket review, and marketing authorization.

     Understanding the product: If an organization submits information they gathered during a Review Determination Pre-Submission, the   FDA will use that information to better understand the product by also interactively working with the program participant.

     Premarket Review: Currently there are several proposed ways to perform the review, such as evaluating the software’s analytical performance, clinical performance, and appropriate safety measures.

     Marketing Authorization: FDA will finalize the premarket decision, document the summary, keep the records on which the decision was based, and communicate the decision to the organization.

Below are the following streamlined review elements stated by the FDA:

Real-World Performance: this process will provide organizations with real-world data after the launch. By collecting and analyzing these data elements, organizations will utilize these data for quality control and product development.

Real-World Performance analytic, or RWPA, will use three types of analyses: Real-World Health Analytic (RWHA), User Experience Analytic (UXA), and Product Performance Analytic (PPA).

RWHA: are defined as analyses of real-world clinical outputs and outcomes related to the intended use of the SaMD product.

UXA: are defined as analyses of user experience outputs related to the real-world use of a SaMD product.

PPA: are defined as analyses of outputs and outcomes demonstrating the real-world accuracy, reliability, and security of a SaMD product.


Benefit of Pre-Cert Program

FDA states that through Pre-Certification Pilot Program, they aim to do the following:

  • Organizations with “precertified” status will have the ability to participate in a streamlined premarket review and opportunities to collect and leverage real-world postmarket data.
  • Leverage and use information from all available sources allowing FDA and SaMD manufacturers to be more efficient and streamlining the products without compromising safety and effectiveness of SaMD products.
  • Potentially allow pre-certified organizations to market their lower-risk devices without FDA premarket review.
  • Enable a modern and tailored approach that allows software iterations and changes to occur in a timely fashion.
  • Ensure high-quality software products throughout the life of the product by enabling companies to demonstrate their embedded culture of quality and organizational excellence.
  • Adapt key elements and measure based on the effectiveness of the program.

To learn about how to submit comments on the Pre-Cert program, click

To view the FDA’s full version of the working model of Pre-Cert program, click here

About medical device regulations: