Imagine if you spent the last 6 months and $40,000 testing your new device in order to submit a 510(k). The week before Christmas you submitted your 510(k) and this week you are returning to work in anticipation of receiving confirmation that your submission has passed the RTA screening process. When you open your email on Thursday morning you find that you received an RTA hold letter instead.

On page 19 of the attached RTA checklist you see that question 32 has a comment about your electrical safety testing. You performed testing to IEC 60601-1, because that is electrical safety standard for medical devices. However, the reviewer is asking for a justification for why you did not test your device to IEC 60601-1-11:2015.

You learn that the -1-11 collateral standard is specific to home use devices.like yours. You need to repeat testing to the new standard or provide a justification for not doing this testing. How much will this cost? Why didn’t the UL testing lab mention this?

The most important part of new product development is to ensure that you properly identified the required design inputs. Inputs include the electrical safety, EMC and performance testing standards that are applicable to your type of device. Special controls guidance documents might have been written in 2007 and the standards are probably out of date.

Experienced regulatory professionals create a regulatory pathway analysis first to make sure all the inputs are properly identified. The regulatory pathway analysis has to be systematic and thorough. It’s too easy to miss one standard and delay 510(k) clearance by months.

You can reduce risk by requesting an FDA pre-sub meeting before you begin your testing. However, you need to request this 75-90 days prior to your “design freeze.”

About 50% of the time I find there is no special controls guidance document specific to a device, but there are a number of predicates. Key information needed is the technological details of the device, such as: material, power source, mode of operation and design features.

First you identify the product classification. I wrote a blog on this topic:

http://medicaldeviceacademy.com/fda-device-classification/

Sometimes the product classification does not include a special controls guidance document and predicates listed for the product classification are 5+ years old. Relying upon a review of 510(k) summaries is not enough. Are there other generic guidance documents specific to the technology your device uses?

Are any of the standards listed for safety and performance testing of predicates in the process of being revised?

Sometimes standards are already revised, but the FDA might not recognize the standard until several years after its release. A competitor may reference an older standard that is now superseded by a new version.

Once you have an RTA hold letter, you need to figure out what the current standards are for testing and understand how you missed the standard mentioned by the FDA reviewer. Maybe there is a scientific rationale why you don’t need this new one. Once you are 100% confident you have the right answer, I recommend that you contact the FDA reviewer and explain your planned response to the question. You want the FDA reviewer to provide some feedback so that you don’t make this mistake again. Sometimes the FDA may insist upon a pre-sub meeting to answer this question, but it’s always worth an email or phone call to the reviewer.

Good luck with your submissions in 2017. I’ll be wishing for your inbox to be full of acceptance letters instead of RTA hold letters.

Happy New Year!

source: https://www.linkedin.com/groups/2070960/2070960-6221699343594848257