Return-Path: Delivered-To: louk@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id uGo6DNIBtVrabAAAInt2oQ for ; Fri, 23 Mar 2018 06:32:02 -0700 Return-path: Envelope-to: louk@transocean.com Delivery-date: Fri, 23 Mar 2018 06:32:02 -0700 Received: from omp.news.grceducators.com ([129.145.68.217]:39314 helo=om-axonstech.rsys2.com) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1ezMnT-0007PC-Of for louk@transocean.com; Fri, 23 Mar 2018 06:32:02 -0700 DKIM-Signature: v=1; a=rsa-sha256; c=relaxed/relaxed; s=grceducators; d=news.grceducators.com; h=MIME-Version:Content-Type:Content-Transfer-Encoding:Date:To:From:Reply-To: Subject:List-Unsubscribe:Message-ID; i=grceducators@news.grceducators.com; bh=RzNsGrYtZlaW5DZCP+n0g8OPpLEzc2+7DbTUNzy+hvQ=; b=TM1dA5v4zdHvDjKDKrIt0JJNIBHQSUxH6fyofJImiHeWaIua93Hk7A64MGPf7aOcwjSH6At0XYZ+ Zb7yWCWmk3wxTFAdzEM00m/Uw6PhZHHNwZBI9wlbHvTJ5PREE5TnQUXwqDrAXvAQgDesWWV3P758 96il+2am5PeZsCIPvJplioZz2u/z2T7rtMZXgWyBP8XwNaT/fbmflwoPjV9pprqx4UBkk3R79TSP FXoFLQKA94nKhS31Tkjq8cfK2lqpETJvRUMqUxMBz/6MwjRFR8mR33IdqrVUvUIsC8GWJowlFbcS MJshBb0DoT4ZIU5TPpL89Ayky2M8rSFpW3l7Og== Received: by om-axonstech.rsys2.com id hmk0so2b610p for ; Fri, 23 Mar 2018 06:31:15 -0700 (envelope-from ) X-CSA-Complaints: whitelist-complaints@eco.de MIME-Version: 1.0 Content-Type: text/html; charset="ISO-8859-1" Content-Transfer-Encoding: quoted-printable Date: Fri, 23 Mar 2018 06:31:15 -0700 To: louk@transocean.com From: =?ISO-8859-1?B?V2ViaW5hciB1cGRhdGVz?= Reply-To: =?ISO-8859-1?B?V2ViaW5hciB1cGRhdGVz?= Subject: De Novo Classification Process Feedback-ID: 10775:134262:oraclersys List-Unsubscribe: , X-sgxh1: thmsxljHgkhJLHgQJhu X-rext: 5.interact2.EkuxNoQTKWwhsTypaAKx8IRHbk-OVBVmTx8t46tMzSCoDR4 X-cid: axonstech.137362 Message-ID: <0.1.8F.1B9.1D3C2AB37F8DEC6.0@om-axonstech.rsys2.com> X-Spam-Status: No, score=2.4 X-Spam-Score: 24 X-Spam-Bar: ++ X-Ham-Report: Spam detection software, running on the system "vps.transocean.com", has NOT identified this incoming email as spam. The original message has been attached to this so you can view it or label similar future email. If you have any questions, see root\@localhost for details. Content preview: FDA Review Process for a De Novo application 740-870-0321 De Novo Classification Process [...] Content analysis details: (2.4 points, 3.0 required) pts rule name description ---- ---------------------- -------------------------------------------------- 0.0 URIBL_BLOCKED ADMINISTRATOR NOTICE: The query to URIBL was blocked. See http://wiki.apache.org/spamassassin/DnsBlocklists#dnsbl-block for more information. [URIs: grceducators.com] -0.0 T_RP_MATCHES_RCVD Envelope sender domain matches handover relay domain -0.0 SPF_PASS SPF: sender matches SPF record 0.0 HTML_FONT_LOW_CONTRAST BODY: HTML font color similar or identical to background 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts 0.0 HTML_MESSAGE BODY: HTML included in message 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.4971] 0.1 DKIM_SIGNED Message has a DKIM or DK signature, not necessarily valid -0.1 DKIM_VALID Message has at least one valid DKIM or DK signature -0.1 DKIM_VALID_AU Message has a valid DKIM or DK signature from author's domain 1.0 FROM_EXCESS_BASE64 From: base64 encoded unnecessarily X-Spam-Flag: NO <=21DOCTYPE html PUBLIC =22-//W3C//DTD XHTML 1=2E0 Transitional//EN=22 =22h= ttp://www=2Ew3=2Eorg/TR/xhtml1/DTD/xhtml1-transitional=2Edtd=22> FDA Review Process for a De Novo application <=21--=5Bif gte mso 11=5D><=21=5Bendif= =5D--><=21--=5Bif =21mso=5D><=21--> <=21--<=21=5Bendif=5D--><=21--=5Bif gte mso 15=5D>96<=21=5Bendif=5D--><=21--=5Bif gte mso 9=5D>96<=21=5Bendif=5D-->
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740-870-0321
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De Novo Classification Process
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FRIDAY APRIL 20 2018  =7C 01:00 PM EST  = =7C 60 MINUTES
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A new type of device may be eligible for the de novo = process if it has received an NSE determination because of a 510(k) submiss= ion=2E The submitter of the 510(k), within thirty (30) days of receipt of a= n NSE determination, submit a De Novo petition requesting that a risk-based= classification determination be undertaken=2E The petition must include a = description of the device with detailed information and the reasons for any= recommended classification=2E The FDA must make a classification determina= tion for the device that is the subject of the petition by written order wi= thin sixty (60) days of the request=2E

If FDA grants the de novo petition, the device is reclassifi= ed from Class III into Class I or Class II allowing the device to be then m= arketed and serve as a predicate device=2E

If the petition is denied, the device remains in Class III a= nd may not be marketed=2E

This webinar will follow this pathway explaining the process= that must be followed to assure the most potential for a successful outcom= e=2E

A device can only be moved out of Class III in this situatio= n only through a reclassification process=2E The De Novo process provides a= possible route to marketing a low risk device type=2E Unfortunately, this = process remains one of the least utilized routes to the marketing of these = devices=2E This webinar will examine and define De Novo and discuss the key= elements of this classification process=2E
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