In this first BiocompCHATibility Podcast episode of 2023, our hosts are happy to introduce

a new podcast to the NAMSA family, and talk a little bit to the hosts about the insightful

topics to come.

This new, conversational podcast will feature a new set of hosts who dedicate each

episode to trending regulatory and quality affairs topics within the MedTech industry.

Future topics include:

• Refuse to Accept Policy for 510(k)s – This episode will delve into the procedures

and criteria FDA intends to 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.

• FDA Releases Draft Guidance: Content of Premarket Submissions for Device

Software Functions – As a follow-up to one of NAMSA’s recent blog posts, our

hosts will describe information that the FDA deems important during its

evaluation of the safety and effectiveness of device software with one or more

device functions.

• Compliance Pitfalls (Start-up Focus) – This episode will focus on common

compliance obstacles faced when dealing with documenting procedures,

complaint handling processes, supplier controls, audit & training, laboratory

controls, monitoring and calibration and more.