RE:RE:HC approval processthere was a PDF that had a flow chart but i cant seem to locate this on the HC website, i may have been a bit off in my 84 day estimate. I did find this on HC website though.
we are within 6 months from Dec application and there wasnt a rejection, so we should be in review 2? 30+15=45 + 3 week (21 days) = 76 days July 29th + 76 days = oct 13 ish ... so mid Oct?
Attachment 1
Interim target performance standards for management of applications for medical device licenses and investigational testing authorizations | |
| Investigational testing | 30 | 30 |
| Class ii licence | 15 | 15 |
| Class III licence | 15 | 60 | 15 | 30 |
| Class IV licence | 15 | 75 | 15 | 30 |
Priority review
Class III & IV Licence | 45 | 15 |
| Licence amendment: i) Significant Change
(Class III and IV) | 15 | 60 | 15 | 30 |
| ii) Significant Change (Class IV) | 15 | 75 | 15 | 30 |
iii) Administrative
Change - Faxback Forms
(all classes) | 15 | 15 |
TARGET = 90% of the submissions in a category to be processed withing the time shown.
(Screening 2 and Review 2: the screening and review of additional information requested during the review of an application or amendment).