,,ii #aaith ,,congress #ast ,session ,s4 #cdba ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #aj1 #bjbe,mr4 ,durbin introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to improve medical device recall notifications by amending the ,federal ,food1 ,drug1 and ,cosmetic ,act to establish an electronic format for device recall notifications1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,medical ,device ,recall ,improvement ,act of #bjbe4 #b4 ,regulation of medical device recalls ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq471 is amended by inserting after section #eah;,a of such ,act the following3 #eah;,b4 ,electronic notification format for device recalls 7a7 ,electronic notification format for device recalls 7#a7 ,in general ,not later than #b years after the date of enactment of the ,medical ,device ,recall ,improvement ,act of #bjbe1 the ,secretary shall publish a form and manner for notifications of a recall4 7#b7 ,content ,the form and manner prescribed by the ,secretary under paragraph 7#a7 shall-- 7,a7 be electronic2 7,b7 include mandatory data elements1 including-- 7i7 the name of the manufacturer or importer2 7ii7 the contact information and address of the manufacturer or importer2 7iii7 the specific reason for the correction or removal from the market of the device2 7iv7 the specific device of the manufacturer or importer subject to such recall2 7v7 the unique device identifier of the device1 including1 as applicable1 the device identifier and any production identifier2 7vi7 information for device user facilities and health professionals with regard to the device and such recall2 and 7vii7 information for patients with regard to the device and such recall1 including-- 7,i7 the risk presented by the device2 and 7,,ii7 any action that may be taken by1 or on behalf of1 such patients to eliminate or reduce such risk2 and 7,c7 include optional data elements as the ,secretary determines to be appropriate4 7b7 ,notifications 7#a7 ,notifications to the ,secretary 7,a7 ,in general ,beginning #ahj days after the ,secretary establishes the form and manner for recall notifications under subsection 7a71 a manufacturer or importer of a device shall submit notifications required under section #eai7;g7 to the ,secretary through the electronic notification format established under subsection 7a74 7,b7 ,review requirement 7i7 ,initial review ,not later than #b business days after receipt of a notification described in subparagraph 7,a71 the ,secretary shall conduct an initial review of such notification4 7ii7 ,response of the ,secretary ,not later than #c business days after the completion of such review1 the ,secretary shall inform the manufacturer or importer of the information the ,secretary determines1 through the initial review under clause 7i71 should be shared with device user facilities and health professionals4 7#b7 ,notifications to device user facilities and health professionals 7,a7 ,initial notifications ,a manufacturer or importer shall submit notifications to device user facilities and health professionals through the electronic notification format established under subsection 7a7 after an initial review by the ,secretary is completed under paragraph 7#a77;,b77i74 7,b7 ,subsequent notifications ,a manufacturer or importer shall provide notifications in addition to those described in subparagraph 7,a71 as necessary1 to device user facilities or health professionals through the electronic notification format established under subsection 7a74 7c7 ,electronic database ,the ,secretary shall maintain an electronic database that is publicly accessible1 downloadable1 and populated with information regarding device notifications made under this section4 7d7 ,definitions ,in this section and in section #eah;,c-- 7#a7 the term device user facility has the meaning given such term in section #eai7;b77#f72 and 7#b7 the term recall has the meaning given such term in section #eah;,a4 7e7 ,authorization of appropriations ,for purposes of conducting activities under this section and hiring personnel to conduct such activities1 there is authorized to be appropriated #f1gjj1jjj for fiscal year #bjbf1 #a1gjj1jjj for fiscal year #bjbg1 and #a1jjj1jjj for each of fiscal years #bjbh through #bjcj1 to remain available until expended1 without fiscal year limitation4 #eah;,c4 ,patient notification 7a7 ,in general ,the ,secretary shall require that any recall strategy under section #eai7;g7 provides for notice to patients whom device user facilities and health professionals treated with the device4 7b7 ,compliance ,in accordance with subsection 7a71 the ,secretary shall require recall notifications sent from the manufacturer or importer of the device to-- 7#a7 include information for device user facilities and health professionals about the risks presented by the device to patients whom device user facilities and health professionals treated with the device2 and 7#b7 instruct such device user facilities and health professionals to share information under paragraph 7#a7 with patients whom device user facilities and health professionals treated with the device4 7c7 ,affected devices ,subsection 7a7 shall apply with respect to any class ,i or class ,,ii recall for a class ,,ii or class ,,iii device that is used outside of device user facilities and-- 7#a7 implanted in the human body2 7#b7 life-sustaining2 7#c7 life-supporting2 or 7#d7 used significantly in pediatric populations4 7d7 ,rule of construction ,nothing in this section shall be construed to require device user facilities or health professionals to provide patient information to the manufacturer or importer of the device4 4 #c4 ,prohibited acts ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended by adding at the end the following3 7jjj7 ,the refusal or failure to submit notifications in accordance with paragraphs 7#a7 and 7#b7 of section #eah;,b7b74 7kkk7 ,the refusal or failure to provide notice in accordance with section #eah;,c4 4