• 1If a non-FDA regulated product is a desired goal, identify if your product is a mobile medical application (MMA), general wellness product (GWP), clinical decision support software (CDSS) or medical device data system (MDDS) type that the FDA does not intend to regulate.
• 2If your device is a GWP, determine if it is a “category 2” which allows for specific chronic disease condition associations.
• 3If your device is a Category 2 GWP, locate the peer-reviewed scientific publication evidence and/or relevant medical society recommendations supportive of this as required by GWP guidance.
• 4Establish if HIPAA controls are necessary for your product if there are communications between patient and healthcare professionals. This could apply regardless of MMA, GWP, CDSS or MDDS status.
• 5If your digital health company currently has a functional app, software, wearable, or other product, review all text in customer facing user interface (UI), app, website, social media, or other marketing collateral to ensure it is consistent with findings pertaining to service items 1-4 above as they apply and not inadvertently communicating FDA regulated language or claims.
• 6If your product is clearly a FDA regulated medical device, or you wish to electively bring to market a FDA regulated product from the outset, create and execute a strategic plan for FDA registration and QA compliance at a minimum, or 510(k) clearance or de novo classification as applicable, and bring product to market swiftly.
• 7If your product is a FDA regulated medical device, assess if your product is applicable to the Breakthrough Device Designation (BDD) program, and if so execute a pre-submission to be granted BDD to allow for speedier interactions with FDA for 510(k) clearance or de novo classification process.
• 8If your product is a FDA regulated medical device requiring 510(k) clearance or de novo classification, assess and if applicable prepare and submit to FDA a pre-submission (Q-sub) to address major questions that could delay a marketing submission.
• 9If your product is a FDA regulated medical device requiring 510(k) clearance or de novo classification with artificial intelligence (AI) / machine learning (ML) enabled software functions, prepare and submit a predetermined change control plan (PCCP) as part of your marketing submission to allow greatly agility in future AI/ML software changes. Other medical devices may prepare and submit a predetermined change control plan (PCCP) as part of a marketing submission to allow greatly agility in future changes to software or other aspects of product.