5 ms·

Are you building only a QMS or also an automated system to handle registration and listing, CAPA, labeling, submissions, etc? Class 1 all the way to class 3? Al

Are you building only a QMS or also an automated system to handle registration and listing, CAPA, labeling, submissions, etc? Class 1 all the way to class 3? Alternative submission pathways? If you are dealing with digital health products, what are your thoughts on the pre-cert pilot that is occurring right now? How significantly do you believe the changes will impact your process and infrastructure given minimal data about FDA timelines?

enzymejacob 9y ago
Our QMS is an all-inclusive electronic QMS, or eQMS. All quality sub-systems including Document Control, Design Control, Risk Management, Complaint Handling, CAPA, etc. will be integrated.
seehafer 9y ago
To your other questions: Registration and listing: harder to automate because information systems on FDA’s side aren’t quite there yet. For GUDID, yes CAPA, labeling, submissions: yes Alternative submission pathways: what do you mean by this precisely? Pre-cert: I think the premise is correct, in that the current quality system regulations aren’t well suited to modern SW development practice. But the devil will be in the details. Regardless it won’t affect us significantly because whatever gets released will have to have a phase-in for existing process that we’ll be able to adapt to.
- Thriptic 9y ago
  > Alternative submission pathways: what do you mean by this precisely De novos, abbreviated 510(k)s, lesser used pathways. > Pre-cert: I think the premise is correct, in that the current quality system regulations aren’t well suited to modern SW development practice. But the devil will be in the details. Regardless it won’t affect us significantly because whatever gets released will have to have a phase-in for existing process that we’ll be able to adapt to. My general concern being in digital health is implementation timeline. 1 year timeline is different than 2 year timeline is different than 5 year etc. In my eyes it's really a question of how long FDA will be expecting traditional submissions while they roll out a model geared more around approval of companies vs products.
  - seehafer 9y ago
    > De novos, abbreviated 510(k)s, lesser used pathways. De novo’s definitely, abbreviated 510(k)’s as well (that’s more of a requirements -> standard conformance challenge which a system like ours is particularly suited to demonstrate), but to your point they’re not that common. > In my eyes it's really a question of how long FDA will be expecting traditional submissions while they roll out a model geared more around approval of companies vs products. Yes but in a certain sense for many digital health companies this is already true, because they’re 510(k) exempt and FDA’s oversight occurs retroactively via QMS auditing. The near term challenge for digital health, until precert comes online, is that there are a limited number of software experts at FDA. To the Agency’s credit, they have recognized this and are trying to remedy it. But the big problem we see with software submissions is that things get overlooked, and in such a way that speaks to an overworked reviewers. This of course leads to delays, which is why it’s very important for software submissions to be buttoned up. This is one the things we’re tryijg to make happen with our QMS, which generates more reports that clearly map from requirement->code->test.
    - deleted 9y ago
      [deleted]
    - Thriptic 9y ago
      > Yes but in a certain sense for many digital health companies this is already true, because they’re 510(k) exempt and FDA’s oversight occurs retroactively via QMS auditing Yeah fair enough; it's true that there has been a large regulatory shift with the appearance of general wellness and enforcement discretion and the resulting erosion of class 1 and somewhat of class 2. > The near term challenge for digital health, until precert comes online, is that there are a limited number of software experts at FDA. To the Agency’s credit, they have recognized this and are trying to remedy it. But the big problem we see with software submissions is that things get overlooked, and in such a way that speaks to an overworked reviewers. This of course leads to delays, which is why it’s very important for software submissions to be buttoned up. This is one the things we’re tryijg to make happen with our QMS, which generates more reports that clearly map from requirement->code->test. I totally agree with this. If you could create a software submission which efficiently communicated traceability, verification and validation info, and the other key metrics the FDA wanted to see, that would be pretty huge in terms of submission turnaround time. Best of luck guys.
enzymejacob 9y ago
We believe the pre-cert pilot will be transformative for both FDA and digital health companies. FDA is learning from some of the largest software companies how they manage their product life cycles. Apple, Verily and Samsung are aggressively entering the digital health marketplace, so their participation in the pilot alongside large traditional drug and device companies J&J and Roche will be tremendously informative for FDA. Smaller companies on the forefront of digital health approvals such as Pear Therapeutics, Phosphorous and Tidepool will round-out FDA's understanding of how subsequent guidance documents will impact startups in this space. Whether products are SaMD or software-enabled, this industry is on the cusp of exploding with FDA's recent open and progressive approach toward fostering innovation.

enzymejacob 9y ago

Our QMS is an all-inclusive electronic QMS, or eQMS. All quality sub-systems including Document Control, Design Control, Risk Management, Complaint Handling, CAPA, etc. will be integrated.

seehafer 9y ago

To your other questions: Registration and listing: harder to automate because information systems on FDA’s side aren’t quite there yet. For GUDID, yes CAPA, labeling, submissions: yes Alternative submission pathways: what do you mean by this precisely? Pre-cert: I think the premise is correct, in that the current quality system regulations aren’t well suited to modern SW development practice. But the devil will be in the details. Regardless it won’t affect us significantly because whatever gets released will have to have a phase-in for existing process that we’ll be able to adapt to.

Thriptic 9y ago
> Alternative submission pathways: what do you mean by this precisely De novos, abbreviated 510(k)s, lesser used pathways. > Pre-cert: I think the premise is correct, in that the current quality system regulations aren’t well suited to modern SW development practice. But the devil will be in the details. Regardless it won’t affect us significantly because whatever gets released will have to have a phase-in for existing process that we’ll be able to adapt to. My general concern being in digital health is implementation timeline. 1 year timeline is different than 2 year timeline is different than 5 year etc. In my eyes it's really a question of how long FDA will be expecting traditional submissions while they roll out a model geared more around approval of companies vs products.
- seehafer 9y ago
  > De novos, abbreviated 510(k)s, lesser used pathways. De novo’s definitely, abbreviated 510(k)’s as well (that’s more of a requirements -> standard conformance challenge which a system like ours is particularly suited to demonstrate), but to your point they’re not that common. > In my eyes it's really a question of how long FDA will be expecting traditional submissions while they roll out a model geared more around approval of companies vs products. Yes but in a certain sense for many digital health companies this is already true, because they’re 510(k) exempt and FDA’s oversight occurs retroactively via QMS auditing. The near term challenge for digital health, until precert comes online, is that there are a limited number of software experts at FDA. To the Agency’s credit, they have recognized this and are trying to remedy it. But the big problem we see with software submissions is that things get overlooked, and in such a way that speaks to an overworked reviewers. This of course leads to delays, which is why it’s very important for software submissions to be buttoned up. This is one the things we’re tryijg to make happen with our QMS, which generates more reports that clearly map from requirement->code->test.
  - deleted 9y ago
    [deleted]
  - Thriptic 9y ago
    > Yes but in a certain sense for many digital health companies this is already true, because they’re 510(k) exempt and FDA’s oversight occurs retroactively via QMS auditing Yeah fair enough; it's true that there has been a large regulatory shift with the appearance of general wellness and enforcement discretion and the resulting erosion of class 1 and somewhat of class 2. > The near term challenge for digital health, until precert comes online, is that there are a limited number of software experts at FDA. To the Agency’s credit, they have recognized this and are trying to remedy it. But the big problem we see with software submissions is that things get overlooked, and in such a way that speaks to an overworked reviewers. This of course leads to delays, which is why it’s very important for software submissions to be buttoned up. This is one the things we’re tryijg to make happen with our QMS, which generates more reports that clearly map from requirement->code->test. I totally agree with this. If you could create a software submission which efficiently communicated traceability, verification and validation info, and the other key metrics the FDA wanted to see, that would be pretty huge in terms of submission turnaround time. Best of luck guys.

enzymejacob 9y ago

We believe the pre-cert pilot will be transformative for both FDA and digital health companies. FDA is learning from some of the largest software companies how they manage their product life cycles. Apple, Verily and Samsung are aggressively entering the digital health marketplace, so their participation in the pilot alongside large traditional drug and device companies J&J and Roche will be tremendously informative for FDA. Smaller companies on the forefront of digital health approvals such as Pear Therapeutics, Phosphorous and Tidepool will round-out FDA's understanding of how subsequent guidance documents will impact startups in this space. Whether products are SaMD or software-enabled, this industry is on the cusp of exploding with FDA's recent open and progressive approach toward fostering innovation.