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My thoughts on FDA’s Digital Health Precertification Program.

Author: Alex Chang


I applaud FDA for being forward thinking in their intentions to update their traditional regulatory process in their efforts to be more aligned with the 21stCentury. The precertification pilot program for Digital Health products is a move towards the right direction, but I have some reservations.


Back in 2017, FDA took a chance with 23andMe direct-to-consumer’s genetic health risk (GHR) tests and created a framework that allowed 23andMe to bypass premarket notifications for individual GHR tests once they receive approval for their one-time submission. The company was exempt from premarket notification on future genetic tests provided that they maintain a “Quality of Excellence” and follow certain post-market commitments. This milestone helped to shift FDA’s thinking on how they plan to regulate In Vitro Clinical Test (IVCT) as stated in the proposed 2018 VALID Act. This proposal includes a precertification process for IVCT which shared some similarities with the program for digital health products. But more about the VALID Act at another day.


The Precertification Pilot Program for Digital Health Products is a way for FDA to respond to the growing number of digital health products and digital medicine that’s rapidly becoming a critical sector of our health care system. The idea of this program is for FDA to precertify manufacturers of digital health products based on their software design, validation and their post-market commitments. Instead of approving (or clearing) digital health products in a “product-by-product” basis, FDA is putting their trust on the manufacturer’s “culture of quality and organizational excellence.”


What is old is now new. The Clinical Laboratories under CLIA have something similar where CMS would certify the labs and permit them to provide services on non-FDA approved products, such as Lab-developed Tests (LDTs) provided that the lab has trained personnel and that they too demonstrate a “culture of operational excellence.” But we know how the public feels about LDTs and companies like Theranos didn’t do the labs any favors.


If the precertification program becomes the norm, I hope that FDA allows the program to be given the flexibility to adapt to the changes of technology. This pre-cert program may work for today’s digital health products, but we cannot predict how digital health products will evolve in the future, especially with the growth of artificial intelligence and machine learning.


My concern is really about tech giants like Apple, Verily and Fitbit entering into the health industry. While there are brilliant scientists, engineers and programmers in these tech companies, they are still relatively new in understanding the rigorous undertaking in developing a medical product in a health-care environment. I would implore that these tech companies who are new to the health industry to invest heavily on sourcing personnel who are well-versed in navigating the regulatory hurdles.


The precertification pilot program is a gift to companies to reduce the regulatory burden of product submissions to deal with the rapidly evolving changes in technology. I just hope that it’s not a message to manufacturers that FDA is relaxing the regulatory requirements and that regulatory submissions aren’t required for precertified companies. In fact, FDA intends to develop a risk-based framework to aid in the determination on whether a submission is required based on (1) the company’s precertification level and (2) the risk categorization of their products based on the IMDRF risk categorization.


Regardless of whether to submit or not, I hold a long belief that regardless on whether the product needs to be submitted to the agency or not, product development should follow good engineering practices and that they follow the traditional Design Controls process.





Five key points about the Precertification Pilot Program (per FDA’s website):


1. The program consists of nine companies and is limited to manufacturers of software as a medical device (SaMD). At least for now.


2. Manufacturers in this pilot program are to follow the Total Product Lifecycle Approach of the Software Precertification Program.


3. The five principles that FDA is interested in when determining a company’s operation of excellence are: patient safety, product quality, clinical responsibility, cybersecurity responsibility and proactive culture. In addition to the five principles above, FDA also want to see if the company has demonstrated a track record in delivering a safe and effective software product.


4. Review determination will be based on the company’s precertification level and the risk categorization of the product.


5. There is a focus in using real world evidence to provide insight on user’s experience, software performance data and clinical outcomes.


If you are interested in learning more about FDA's working model (version 1) of the Precertification program, please go to: https://www.fda.gov/files/medical%20devices/published/Pre-Cert-Working-Model-v1.0.pdf

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