%PDF-1.3 1 0 obj << /Type /Catalog /Outlines 2 0 R /Pages 3 0 R >> endobj 2 0 obj << /Type /Outlines /Count 0 >> endobj 3 0 obj << /Type /Pages /Kids [6 0 R 37 0 R ] /Count 2 /Resources << /ProcSet 4 0 R /Font << /F1 8 0 R /F2 9 0 R /F3 10 0 R /F4 11 0 R >> /XObject << /I1 12 0 R /I2 13 0 R /I3 36 0 R >> >> /MediaBox [0.000 0.000 595.280 841.890] >> endobj 4 0 obj [/PDF /Text /ImageC ] endobj 5 0 obj << /Creator (DOMPDF) /CreationDate (D:20220603152440-04'00') /ModDate (D:20220603152440-04'00') /Title (FDA Issues Updates for Device Manufacturers) >> endobj 6 0 obj << /Type /Page /Parent 3 0 R /Annots [ 14 0 R 16 0 R 18 0 R 20 0 R 22 0 R 24 0 R 26 0 R 28 0 R 30 0 R 32 0 R 34 0 R ] /Contents 7 0 R >> endobj 7 0 obj << /Length 5656 >> stream 1.000 1.000 1.000 rg 34.016 34.016 527.249 773.859 re f q 441.000 0 0 97.500 45.016 710.374 cm /I2 Do Q 0.000 0.000 0.000 rg BT 45.016 699.385 Td /F1 9.0 Tf [(Published on )] TJ ET BT 99.547 699.385 Td /F2 9.0 Tf [(IVT Network)] TJ ET BT 149.056 699.385 Td /F1 9.0 Tf [( \()] TJ ET BT 154.555 699.385 Td /F1 9.0 Tf [(http://www.ivtnetwork.com)] TJ ET 0.000 0.000 0.000 RG 0.18 w 0 J [ ] 0 d 154.555 698.234 m 259.081 698.234 l S BT 259.081 699.385 Td /F1 9.0 Tf [(\))] TJ ET 0.620 0.620 0.620 rg 45.016 686.888 506.159 0.750 re f 0.000 0.000 0.000 rg BT 45.016 662.142 Td /F3 15.0 Tf [(FDA Issues Updates for Device Manufacturers)] TJ ET q 45.016 610.283 506.159 33.750 re W n 0.800 0.800 0.800 rg 45.016 643.658 13.005 0.750 re f 0.000 0.000 0.000 rg BT 45.016 623.669 Td /F1 9.0 Tf [(By)] TJ ET 0.800 0.800 0.800 rg 58.021 643.658 41.508 0.750 re f 0.000 0.000 0.000 rg BT 58.021 625.544 Td /F4 9.0 Tf [(IVT Staff)] TJ ET 0.800 0.800 0.800 rg 99.529 643.658 114.552 0.750 re f 0.000 0.000 0.000 rg BT 99.529 625.544 Td /F4 9.0 Tf [(Oct 20, 2021 12:55 pm EDT)] TJ ET Q BT 45.016 502.574 Td /F1 10.0 Tf [(The U.S. Food and Drug Administration, FDA, released new guidance for industry this past week. Both impact )] TJ ET BT 45.016 491.686 Td /F1 10.0 Tf [(Medical Device Manufacturers and offer further direction in identification and reporting requirements. The )] TJ ET BT 45.016 480.799 Td /F1 10.0 Tf [(Updates are as follows:)] TJ ET BT 59.416 459.170 Td 1.269 Tw /F1 12.0 Tf [(")] TJ ET BT 63.676 459.170 Td 1.269 Tw /F4 12.0 Tf [(Selected Update for Unique Device Identification: Policy Regarding Global Unique )] TJ ET BT 59.416 446.105 Td 0.000 Tw /F4 12.0 Tf [(Device Identification Database Requirements for Certain Devices)] TJ ET BT 428.860 446.105 Td /F1 12.0 Tf [(")] TJ ET BT 433.120 446.105 Td /F1 10.0 Tf [( \(Draft\))] TJ ET 1.000 1.000 1.000 rg 59.416 359.180 484.559 76.312 re f 0.000 0.000 0.000 rg BT 59.416 423.282 Td 0.371 Tw /F1 10.0 Tf [(The intent of this draft guidance is to update section III of the ")] TJ ET BT 341.289 423.282 Td 0.371 Tw /F1 9.0 Tf [(2020 UDI Compliance Policy Guide)] TJ ET 0.000 0.000 0.000 RG 0.18 w 0 J [ ] 0 d 341.289 422.131 m 483.821 422.131 l S BT 483.821 423.282 Td 0.371 Tw /F1 10.0 Tf [(". The goal is )] TJ ET BT 59.416 408.020 Td 1.971 Tw /F1 10.0 Tf [(to lend further explanation around certain class I devices for which the FDA does not intend to enforce )] TJ ET BT 59.416 392.757 Td 0.238 Tw /F1 9.0 Tf [(Global Unique Device Identification Database)] TJ ET 0.18 w 0 J [ ] 0 d 59.416 391.606 m 241.447 391.606 l S BT 241.447 392.757 Td 0.238 Tw /F1 10.0 Tf [( \(GUDID\) submissions. It provides additional guidance to labelers of )] TJ ET BT 59.416 377.495 Td 1.647 Tw /F1 10.0 Tf [(a class I devices regarding implementation of UDI requirements, as well as meeting the UDI direct mark )] TJ ET BT 59.416 362.232 Td 0.000 Tw /F1 10.0 Tf [(requirements for certain finished device.)] TJ ET 1.000 1.000 1.000 rg 59.416 323.655 484.559 30.525 re f 0.000 0.000 0.000 rg BT 59.416 341.970 Td 1.284 Tw /F1 10.0 Tf [(The draft can be commented within 60 days after its publication onOctober 13, 2021 and is available on)] TJ ET BT 59.416 326.707 Td 0.000 Tw /F1 9.0 Tf [(FDAs website)] TJ ET 0.18 w 0 J [ ] 0 d 59.416 325.556 m 117.925 325.556 l S BT 117.925 326.707 Td /F1 10.0 Tf [(.)] TJ ET 1.000 1.000 1.000 rg 59.416 304.918 484.559 13.736 re f 0.000 0.000 0.000 rg BT 59.416 307.666 Td /F1 9.0 Tf [()] TJ ET BT 62.413 307.666 Td /F4 9.0 Tf [(Investigator Responsibilities Safety Reporting for Investigational Drugs and Devices.)] TJ ET 1.000 1.000 1.000 rg 59.416 254.131 484.559 45.788 re f 0.000 0.000 0.000 rg BT 59.416 287.708 Td 3.354 Tw /F1 10.0 Tf [(This )] TJ ET BT 84.440 287.708 Td 3.354 Tw /F1 9.0 Tf [(new guidance)] TJ ET 0.18 w 0 J [ ] 0 d 84.440 286.557 m 143.324 286.557 l S BT 143.324 287.708 Td 3.354 Tw /F1 10.0 Tf [( outlines the responsibilities regarding safety reporting for investigational drugs and )] TJ ET BT 59.416 272.446 Td 4.504 Tw /F1 10.0 Tf [(devices. The guidance is intended to assist clinical investigators comply with the safety reporting )] TJ ET BT 59.416 257.183 Td 0.000 Tw /F1 10.0 Tf [(requirements for:)] TJ ET BT 62.360 235.681 Td /F1 9.0 Tf [(1.)] TJ ET BT 75.016 232.921 Td /F1 10.0 Tf [(Investigational new drug application \(IND\) studies)] TJ ET BT 62.360 220.418 Td /F1 9.0 Tf [(2.)] TJ ET BT 75.016 217.658 Td /F1 10.0 Tf [(Investigational device exemption \(IDE\) studies)] TJ ET 1.000 1.000 1.000 rg 59.416 190.343 484.559 15.263 re f 0.000 0.000 0.000 rg BT 59.416 193.396 Td /F1 10.0 Tf [(Recommendations are provided to help investigators identify the following:)] TJ ET BT 62.360 171.893 Td /F1 9.0 Tf [(1.)] TJ ET BT 75.016 169.133 Td /F1 10.0 Tf [(For drugs Identify safety information that is considered an unanticipated problem 26 involving risk to )] TJ ET BT 75.016 153.871 Td /F1 10.0 Tf [(human subjects or others and that therefore requires prompt reporting to 27 institutional review boards )] TJ ET BT 75.016 138.608 Td /F1 10.0 Tf [(\(IRBs\) under 312.66 \(21 CFR 312.66\) 28)] TJ ET BT 62.360 126.106 Td /F1 9.0 Tf [(2.)] TJ ET BT 75.016 123.346 Td /F1 10.0 Tf [(For devices Identify safety information that meets the requirements for reporting 30 unanticipated )] TJ ET BT 75.016 108.083 Td /F1 10.0 Tf [(adverse device effects \(UADEs\) to sponsors and IRBs under 31 812.150\(a\)\(1\) \(21 CFR 812.150\(a\)\(1\)\))] TJ ET 0.890 0.929 0.737 RG 1.5 w 0 J [ ] 0 d 64.516 519.533 147.750 82.500 re S q 146.250 0 0 81.000 65.266 520.283 cm /I3 Do Q endstream endobj 8 0 obj << /Type /Font /Subtype /Type1 /Name /F1 /BaseFont /Helvetica /Encoding /WinAnsiEncoding >> endobj 9 0 obj << /Type /Font /Subtype /Type1 /Name /F2 /BaseFont /Helvetica-Oblique /Encoding /WinAnsiEncoding >> endobj 10 0 obj << /Type /Font /Subtype /Type1 /Name /F3 /BaseFont /Times-Roman /Encoding /WinAnsiEncoding >> endobj 11 0 obj << /Type /Font /Subtype /Type1 /Name /F4 /BaseFont /Helvetica-Bold /Encoding /WinAnsiEncoding >> endobj 12 0 obj << /Type /XObject /Subtype /Image /Width 588 /Height 130 /Filter /FlateDecode /DecodeParms << /Predictor 15 /Colors 1 /Columns 588 /BitsPerComponent 8>> /ColorSpace /DeviceGray /BitsPerComponent 8 /Length 8715>> stream x]OK#MDA+x !\K ބ {o/|ygz&Y}Nt]]]UyD~|VVd`蓨CFAgy~u2W!Bm}u%2gSFDK_]惂la蓨-L}U)ϢKݯDFsA0_]恊W"+ Sk<`k
KGF>-2ݓ>NgL$S]-LIF&ۯGF>ֿ"TQX?)_V+֧Rptx{=Qt=އA{ YQnjk:0`vG>ǁɦ[vMB@|^j#Ң-UAw:w*T'=Nh<
F3AIHc[e`vɏċ>/BhQEf.b4@FS!%ʕ )dg靟MQ +[`:@;y=JtL+A"=nz5-"x0mw~ܼrbIۥ@Z~GvK/¨ӰJˉmE Tߞx#
ZUxi9mn=䰟aS:*$,Lu{ͯT=j3aQv{"
ns&oZ>q3x,9h+ `$ D?s:FDSVMU̠hqJRߤ0k5"Adzz37fitvN:ݥd0$ls`҂
Q0VI8݈)ID3TL;d*7`ڹ= 6"
:u9