Medical Devices

CLIA Waiver Decisions for FY2010 (MDUFMA FDA Performance Report October 27, 2010)

#	FDA Decision	FDA Days	MFG Days	Total
1	APPR – Approved	248	38	286
2	APPR – Approved	248	38	286
3	APPR – Approved	398	0	398
4	APPR – Approved	398	0	398
5	DENIED	189	0	189
6	Received in FY09, Not yet complete	33	N/A	N/A
7	Received in FY09, Not yet complete	259	N/A	N/A

#	FDA Decision	FDA Days	MFG Days	Total
1	APPR – Approved	77	0	77
2	APPR – Approved	233	0	233
3	APPR – Approved	204	64	268
4	DENIED	320	426	746
5	DENIED	419	0	419
6	DENIED	172	0	172
7	DENIED	285	0	285
8	DENIED	555	7	562
9	Received in FY10, Not yet complete	121	N/A	N/A