1 |
How will the four levels in the SaMD classification match up with the 3 medical device classifications? |
2 |
Is it possible to get the specifics on how to demonstrate five areas of excellence? |
3 |
How will the four levels in the SaMD classification match up with the 3 medical device classifications? |
4 |
How will review times be reduced? |
5 |
If a company is using a third party developer to code their software, then does the third party also need to be precertified? |
6 |
Will quality system regulation (QSR) requirements be reduced for precertified companies? |
7 |
Does precertification and the streamlined prereview process replace device classifications (I, II, III), 510(k)s, and PMAs? |
8 |
Will FDA clearly identify Design History File and other documentation requirements if they differ from 510(k) and PMA requirements? |
9 |
How will algorithm updates be treated? |
10 |
How will cloud-based software changes be treated? |
11 |
How will FDA encourage smaller companies without an existing business line and a fixed QMS to develop breakthrough/new innovations through regulatory procedures? |
12 |
Right now SaMD will have more postmarket requirements than most devices that have software within the device. How will FDA work through this discrepancy? |
13 |
A software algorithm can be changed within a short time. Sensor devices greater than a nanoscale can be changed within hours. How can FDA speed up their decision-making procedure? |
14 |
FDA has not defined the ramifications around not having precertification or losing precertification. Has FDA defined what would constitute an event where a manufacturer would lose certification? |
15 |
Inspectors looking at postmarket data or device decisions do not have the skillset to determine if you have a business/quality culture. How is FDA going to educate the field investigators so industry is not caught in the middle? |
16 |
Should software intended for a high-risk disease automatically be labeled as a high-risk product? |
17 |
Can a small company without a quality management system be eligible for the Precertification Program? |
18 |
How can a precertified company without a quality management system deal with complaints? |
19 |
How are recalls handled in the Precertification Program and can a modification of a software bug not lead to citation for a recall? |
20 |
What can a company do if FDA wants to remove it from the Precertification Program? |
21 |
To what extent will FDA review records in areas other than product quality in the Precertification Program? |
22 |
Will FDA hire new staff with experience in business excellence to assess a company’s worthiness to enter the Precertification Program? |
23 |
Will there be a user fee for the new Precertification Program? |
24 |
How often will a company have to be reapproved to remain in the Precertification Program? |