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QA/RA Consulting Group Blog

FDA Software Pre-Cert Program Streamlining Premarket Reviews

Updated: Jan 10, 2021

The FDA Software Precertification Program is designed to streamline premarket review for medical device software developers and emphasize post-market data collection. Is it right for you?

What is the Pre-Cert Program?

Throughout 2018, the FDA engaged in a year-long process of completely revamping the Agency’s approach to regulating software. The FDA calls its new program the “Precertification Program.” The FDA’s next step in its Digital Health Innovation Action Plan, the Software Precertification (Pre-Cert) Program is likely to expand the market for innovative new digital health solutions, such as emerging developments in artificial intelligence (AI) and software as medical devices (SaMD) in healthcare. The Pre-Cert Program would permit a medical device software developer to qualify for a more streamlined premarket review while better leveraging post-market data collection on the device’s safety and effectiveness.

Mobile health, or mHealth, systems have been maturing since 1995, but the industry expanded exponentially with the advent of the smartphone. FDA recognized the need for a new approach for digital health oversight and established the Digital Health Program in 2013 to advance this technology by establishing new relationships and fostering collaboration with digital health developers, patients, and providers. In addition, this program is tasked with developing and implementing regulatory strategies, policies, and processes in this area—and then providing transparency and clarity on those policies and processes.

The Pre-Cert Program is the latest development outlined in FDA’s Digital Health Innovation Action Plan. In December 2016, Congress enacted the 21st Century Cures Act, which fundamentally changed the scope of FDA regulation of clinical decision support software. In December 2017, the FDA published a draft guidance building on that legislation, providing the agency’s perspective on the clinical decision support software that the FDA should regulate and what it should not. That guidance has profound implications for artificial intelligence used to guide healthcare decision-making.

Currently being tested, the Program will be a voluntary pathway providing a streamlined regulatory approach to SaMD review, replacing the need for a premarket submission, or allowing for streamlined premarket review that maximizes efficiency and engagement for higher risk devices.

Ultimately, the product types that may benefit from precertification might include all software that meets the definition of a device in § 201(h)1 of the Food, Drug and Cosmetic Act (FDCA) including SaMD, software in a medical device (SiMD), and other software that could be considered accessories to hardware medical devices. However, the current focus is to establish processes for SaMD technologies, which may include software functions that use artificial intelligence and machine learning algorithms.

Software developers would be assessed (by FDA or by an FDA-accredited third party) for the rigor of their practices in software design, testing, clinical assessment, and real-world performance monitoring, along with other appropriate capabilities. A successful assessment would permit the organization to qualify for a more streamlined premarket review while better leveraging post-market data collection on the device’s safety and effectiveness.

The concept is based upon precertification of software manufacturers who have demonstrated a culture of quality and organizational excellence. The five “Excellence Principles” include: (1) Product Quality, (2) Patient Safety, (3) Clinical Responsibility, (4) Cybersecurity Responsibility, and (5) a Proactive Culture.

The FDA intends to leverage relevant existing standards and certifications from accredited bodies as acceptable evidence to demonstrate CQOE where possible to support a least burdensome approach to the Excellence Appraisal of an organization and to avoid unnecessary complexity. However, FDA does not intend to include a specific standard or certification as a requirement of the Excellence Appraisal or Precertification Program. FDA will likely consider ISO 13485:2016 certificates and Medical Device Single Audit Program (MDSAP) participation as part of the Excellence Appraisal.

Precertification Program Panel

Don't Miss the Roadshow on March 26, 2019

Scott Bednar, Founder and Principal at QA/RA Consulting Group, will be discussing the pros and cons of participating in FDA’s new Pre-Certification Program as a panelist at the Swartz Center for Entrepreneurship in the Taubman A. Alfred Biomedical Science Research Building (BSRB), Kahn Auditorium located at Carnegie Mellon University on March 26, 2019, during the The National Startup Roadshow – AI in Healthcare, a unique program that focuses on entrepreneurs and experienced developers of artificial intelligence for the health care industry. Guests will hear from experts in the medical software community who are already subject to FDA regulation, including experienced medical software executives and attorneys.

Following the panel discussion, Entrepreneur Office Hours will be available from 12:30pm-2:30pm for entrepreneurs to ask questions and learn more about specific interest areas. Visitors may sign up for 20-minute individual sessions:

Track 1: Is my software regulated?

Track 2: What is my best path to market? And other questions associated with regulated software

Join Scott Bednar at The National Startup Roadshow – AI in Healthcare, Carnegie Mellon University on March 26, 2019 to answer your questions about FDA’s new Pre-Cert program and how the 21st Century Cures Act changes the scope of FDA regulations, or contact us.

1 commento

Membro sconosciuto
31 ott 2022

Operon Strategist is a medical device regulatory consulting company which provides regulatory advisory & guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.


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