In our fourth episode of NAMSA's RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Sonia Lecce (Principal IVD Regulatory Consultant) and Duan Threats (Senior IVD Regulatory Consultant).

During the discussion, Sonia and Duan delve into the differences between SiMD and SaMD for In Vitro Diagnostics (IVD), as well as FDA criteria deemed important during evaluation of safety and effectiveness of IVD software with one or more device functions.

“Things have changed in diagnostics tremendously; they have brought diagnostics to the forefront as a norm rather than an afterthought” – Sonia Lecce (Principal IVD Regulatory Consultant)

Discussion topics include:

• What criteria classify a device as either SiMD or SaMD for IVDs?
• What regulatory agencies are taking the lead on future IVD regulations?

What are the differences between Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD)? In this third episode of NAMSA's RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Lezlie Hynes (Principal Quality Consultant) and Monica R. Montanez (Principal Product Development Strategist).

During the discussion, they delve into the differences between SiMD and SaMD, as well as FDA criteria deemed important during evaluation of the safety and effectiveness of device software with one or more device functions.

“I get a lot of questions related to the FDA guidance document. Most sponsors do not really take that guidance document seriously and the FDA does. Every element in that guidance document needs to be considered. ” – Monica Montanez, Principle Product Development Strategist

Discussion topics include:

• What criteria are utilized to classify a device as either SiMD or SaMD?
• Are certain regulatory agencies taking the lead on future regulations?
• How can we better understand digital health trends?

What is the FDA’s Refuse to Accept Policy? In this second episode of NAMSA's RAQA Café Podcast, we are joined by NAMSA’s Principal Product Development Strategist, Angela Mallery, to examine the procedures and criteria FDA use in assessing whether a premarket notification 510(k) submission meets a minimum threshold of acceptability, and if it should be accepted for substantive review. Also discussed during this podcast is FDA’s voluntary eSTAR (electronic Submission Template and Resource) program, which aligns with FDA’s internal review template and integration of guidance expectations.

“When you are doing your 510(k), you should set up your expectations with management far, far ahead so they don’t have the expectation that 90 days later they are going to be able to sell the product. Setting these expectations is one of the things the regulatory person should do… The whole process generally takes four to six months.” – Angela Mallery

Discussion topics include:

• FDA Refusal to Accept (RTA) screening process 510k submissions
• RTA Checklist (Traditional 510k, Abbreviated 510k, Special 510k)
• FDA eSTAR Program, a voluntary electronic submission template

Finding the right consultant is crucial to the success of your project. In this first episode of NAMSA’s RAQA Café Podcast, our hosts, joined by two guest speakers, delve into the many aspects that must be considered when choosing the best consultant for your product development needs. Providing perspectives from both large-scale manufacturers and small startups, our guest speakers help highlight the different needs that each type of customer requires.

“I think that communication is important with your consultant or CRO. Finding one that you can communicate with, that they understand your needs, that you can have an open conversation, … that is really important.” - Carol Buchert, Senior Manager, NA Regulatory & Quality

Discussion topics include:

• Determining if the consultant’s technical experience matches your development needs
• Navigating communication expectations
• Defining clear responsibilities during project scoping
• Understanding future support capabilities