Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

DESCRIPTION

Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device industry. How are regulators keeping pace with its growth? FDA has a set of specific requirements unique to SaMD that companies are expected to meet in order to market these devices in the United States.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Andrew Frink, regulatory affairs manager at Proxima Clinical Research (CRO) about the ways in which SaMD companies can improve final submission outcomes of these devices by leveraging Pre-submissions to FDA, which involves meeting the agency's applicable regulatory guidelines and pre-sub expectations.

Some highlights of this episode include:

• Pre-sub preparation: When a medical device and/or software company wants to expand, the first step with FDA should be a pre-submission meeting to present a packet of information for formal feedback.
• Follow FDA’s guidance documents to know and understand the differences between pre-submission expectations and requirements for 510(k), De Novo, and SaMD regulatory pathways.
• Pre-sub benefits: Save time and money by starting a dialogue to move forward with confidence based on FDA’s formal feedback about achieving regulatory requirements and intended use.
• Minimum Pre-submission must-haves:
  - Detailed and clear device description
  - Intended use statement with medical benefits and impact
  - Target audience description (patient population and intended users)
  - User interface screenshots and device output
  - Risk hazard analysis and mitigation for level of concern
  - Verification and validation plan/outline
  - Software development process documentation (Agile, waterfall, etc.)
  - Cyber security description
  - Off-the-shelf software/code use of unknown pedigree (AWS, Docker, etc.)

Memorable quotes from this episode:

“A pre-sub is vital to almost any submission to the FDA. It’s a chance to get formal feedback from FDA.” Andrew Frink

“What do I need to provide to FDA? Software is a little bit different. It’s not tangible good. It’s not something I can hold in my hand per se.” Jon Speer

“One thing that most software developers struggle with is this intended use statement. This is one of the most critical pieces of information that you can give to the FDA.”  Andrew Frink

“FDA is very open to different software development systems. They do want you to document and describe your software development environment.” Andrew Frink