Out They Go – FDA Clears the Store of Guidances

25 October 2019 |

End of financial year

In a now traditional clearing of the store, FDA issued a raft of new guidances at the close of the financial year. Through September to October 10 a total of 17 new Final Guidance documents issued from CDRH.

510(k) Submissions

A package of seven new or revised guidances covers multiple aspects of the 510(k) clearance processes. There’s much to digest here including updates on the Abbreviated and Special 510(k) pathways, detail on how the review clock system works (hint: a bit like speed chess, although not so speedy) advice on submission format and very important advice on the Refuse to Accept Policy.

Anyone planning submission of a 510(k) needs to understand Refuse to Accept. FDA effectively applies a pre-screen to all submissions, which is a check that the submission is complete and correctly compiled. The guidance helpfully sets out how that is done.

Want to avoid falling at the first hurdle? Read the guidance and carry out the screen yourself.

And rounding out the 510(k) chapter…new guidance on user fees and refunds for de novo submissions.


High on the best-seller list is the updated guidance on mobile apps. The new version actually combines advice for software on both mobile (defined as hand held) and “general purpose computing platforms”, not hand-held, a.k.a. computers. This is a welcome approach. It reinforces that the principles underlying software regulation are agnostic to the platform. And it sets out the FDA pain points, and the stuff where FDA intends to exercise “enforcement discretion” i.e. look the other way as they have bigger fish to fry elsewhere. Nothing particularly new here, although there are more precise definitions and a range of useful examples:

What’s Hot: FDA will regulate software that:
• Controls another device or
• Includes sensors or special attachments that turn a generic platform into a specialist device (think an attached glucose strip reader on a smartphone)
• Contains algorithms that that undertake sophisticated analysis resulting in patient specific diagnostic or therapeutic recommendations

What’s Not: FDA will not regulate anything that:
• Supports self-management without generating patient-specific advice (general wellness or guidance apps)
• Manages records, provide for easy patient-physician communications or easy access to information – things like lookups of drug-drug interactions. Think of these as effectively electronic books or record systems.

Also in the software category – new guidance on Off-the-Shelf software, and on Medical Device Data Systems (including image storage and communication devices) and an overview of how FDA software policy has evolved in response to the 21st Century Cures Act.

Safety and Performance Pathway

A much-heralded evolution of the 510(k) ecosystem is a new Safety and Performance Pathway where a new device can meet 510(k) substantial equivalence requirements by demonstration of compliance with accepted safety and performance standards. The logic is that FDA will, by reference to existing cleared devices, devise a set of explicit safety and performance requirements to which devices of the type comply. Meet these and you are considered equivalent to other cleared devices. FDA has more work to do to get this approach off the ground: the guidance states

“FDA intends to maintain a list of device types appropriate for the Safety and Performance Based Pathway on the FDA website for the Safety and Performance Based Pathway,10 accompanied by the guidance documents that identify the performance criteria for each device type, as well as the testing methods recommended in the guidances where feasible, and any other relevant information.”

Device Specific

Finally, amongst all the big picture stuff, are three new device specific documents:

Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labelling Considerations
Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labelling
General Wellness: Policy for Low Risk Devices

And of course, this end of year cleaning house leaves space for a whole new set of guidance development. See here for what’s on FDA’s mind for the coming year.

Link: List of most recent Device Guidances

If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)


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