Questions for FDA about precertification of software as a medical device from the Diabetes Technology Society meeting, August 28, 2018
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?