FDA Home Page<\/a> EU Medical Device Regulation [pdf]<\/a> Health Canada Home Page<\/a> International Standards Organization (ISO)<\/a> Online Search of FDA Guidances<\/a> FDA Law Blog – Hyman, Phelps & McNamara<\/a><\/p>\n Regulatory Affairs Professional Society (RAPS)<\/a> Medical Device and Diagnostic Industry (MDDI)<\/a> Food and Drug Administration FDA Home Page FDA Center for Devices and Radiologic Health (CDRH) Online Search of CFR Title 21 – Food and Drugs: Parts 1 to 1499 (FDA) CDRH Databases Federal Food, Drug, and Cosmetic Act Online Search of the Federal Register (GPO-FDsys) Online Search of the Code of Federal Regulations (GPO-FDsys) Device […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-28","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/pages\/28","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.smestad.net\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=28"}],"version-history":[{"count":29,"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/pages\/28\/revisions"}],"predecessor-version":[{"id":209,"href":"https:\/\/www.smestad.net\/index.php?rest_route=\/wp\/v2\/pages\/28\/revisions\/209"}],"wp:attachment":[{"href":"https:\/\/www.smestad.net\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=28"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nFDA Center for Devices and Radiologic Health (CDRH)<\/a>
\nOnline Search of CFR Title 21 – Food and Drugs: Parts 1 to 1499 (FDA)<\/a>
\nCDRH Databases<\/a>
\nFederal Food, Drug, and Cosmetic Act<\/a>
\nOnline Search of the Federal Register (GPO-FDsys)<\/a>
\nOnline Search of the Code of Federal Regulations (GPO-FDsys)<\/a>
\nDevice Advice<\/a><\/p>\nEuropean Union<\/h2>\n
\nConsolidated Medical Device Directive [pdf]<\/a>
\nHarmonized Standards related to the Medical Device Directive<\/a>
\nGuidelines related to the Medical Device Directive (MEDDEV)<\/a>
\nTeam NB – Notified Body Recommendations (NB-MED)<\/a>
\nMedical Device Coordination Group (MDCG) Documents<\/a>
\nNotified Body Operations Group (NBOG) Documents<\/a>
\nInternational Medical Device Regulators Forum (IMDRF) Documents<\/a><\/p>\nHealth Canada<\/h2>\n
\nMedical Devices<\/a>
\nActs and Regulations<\/a>
\nCompliance and Enforcement\/Mandatory Problem Reporting<\/a>
\nCanadian Medical Devices Regulations [pdf]<\/a><\/p>\nStandards<\/h2>\n
\nAssociation for the Advancement of Medical Instrumentation (AAMI)<\/a>
\nAmerican National Standards Institute (ANSI)<\/a>
\nEuropean Committee for Electrotechnical Standardization (CENELEC)<\/a><\/p>\nGuidances<\/h2>\n
\nInternational Medical Device Regulators Forum<\/a>
\nInternational Conference on Harmonisation (ICH)<\/a><\/p>\nBlogs<\/h2>\n
Professional Organizations<\/h2>\n
\nAmerican Society for Quality (ASQ)<\/a>
\nParenteral Drug Association (PDA)<\/a>
\nAdvaMed<\/a><\/p>\nTrade Magazines and Supplier Directories<\/h2>\n
\nQmed.com<\/a>
\nBiopharm International<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"