{"id":776,"date":"2018-05-08T11:19:27","date_gmt":"2018-05-08T11:19:27","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/fda-guidance\/"},"modified":"2026-04-29T09:56:40","modified_gmt":"2026-04-29T13:56:40","slug":"fda-guidance","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/fda-guidance\/","title":{"rendered":"FDA guidance &#8211; General, Drug and Biologicals, Medical Devices, and FDA operations"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[44,66,75],"update-type":[],"class_list":["post-776","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-guidance","topic-fda-drugs-devices-biologics","topic-investigator-study-team-responsibilities","topic-regulations-policies-federal-state-local"],"acf":{"use_legacy_editor":true,"updated_date":"2020-11-02 15:15:00","update_notice":false,"author":"IRBMED","summary":"The term \u201c<a class=\"gtip\" href=\"\/medschool\/glossary\/test-article\">test article<\/a>\u201d is found in the <a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a> regulations on Protection of <a class=\"gtip\" href=\"\/medschool\/glossary\/human-subject-0\">Human Subjects<\/a> (<a class=\"gtip\" href=\"\/medschool\/glossary\/21-cfr%E2%80%A6\">21 CFR<\/a> 50.3, Definitions (j)).\u00a0The term includes drugs (including botanicals, <a class=\"gtip\" href=\"\/medschool\/glossary\/biological\">biologicals<\/a>, and gene therapy, and genetically derived products that meet the definition of a \u201cdrug\u201d), and <a class=\"gtip\" href=\"\/medschool\/glossary\/medical-device\">medical devices<\/a> for human use. The FDA has statutory authority to regulate the development and marketing of these products.","button_links":null,"related_content":[763,872,884],"legacy_path":"fda-guidance","legacy_node_id":318,"legacy_related_nids":"305, 1005, 1537","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"General","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<ul>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/ucm126420.htm\">Frequently Asked Questions<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/ucm126422.htm\">Cooperative Research<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/ucm126423.htm\">Non-local IRB Review<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/downloads\/RegulatoryInformation\/Guidances\/UCM294558.pdf\">Continuing Review After Study Approval<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/ucm126425.htm\">Sponsor - Investigator - IRB Interrelationship<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/media\/83209\/download\">Foreign Clinical Studies, Acceptance of<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/ucm126427.htm\">Charging for Investigational Products<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/ucm126428.htm\">Recruiting Study Subjects<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/ucm126429.htm\">Payment to Research Subjects<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/ucm126430.htm\">Screening Tests Prior to Study Enrollment<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/ucm126431.htm\">Informed Consent, A Guide to<\/a><\/li>\r\n \t<li><a href=\"http:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/ucm126432.htm\">Use of Investigational Products When Subjects Enter a Second Institution<\/a><\/li>\r\n \t<li><a href=\"http:\/\/www.fda.gov\/downloads\/RegulatoryInformation\/Guidances\/UCM249673.pdf\">Exception from Informed Consent Requirements for Emergency Research<\/a><\/li>\r\n \t<li><a href=\"http:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/ucm126486.htm\">\"Off-Label\" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices<\/a><\/li>\r\n<\/ul>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Drugs and Biologics","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<ul>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/ucm126491.htm\">Emergency Use of an Investigational Drug or Biologic<\/a><\/li>\r\n \t<li><a href=\"http:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/ucm126495.htm\">Treatment Use of Investigational Drugs<\/a><\/li>\r\n \t<li><a href=\"http:\/\/www.fda.gov\/downloads\/RegulatoryInformation\/Guidances\/UCM126500.pdf\">Waiver of IRB Requirements for Drug and Biological Product Studies<\/a><\/li>\r\n \t<li><a href=\"http:\/\/www.fda.gov\/RegulatoryInformation\/Guidances\/ucm126501.htm\">Drug Study Designs<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/evaluation-gender-differences-clinical-investigations\">Evaluation of Gender Differences<\/a><\/li>\r\n \t<li><a href=\"http:\/\/www.fda.gov\/downloads\/RegulatoryInformation\/Guidances\/UCM214282.pdf\">Frequently Asked Questions \u2013 Statement of Investigator (Form FDA 1572)<\/a><\/li>\r\n<\/ul>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Medical Devices","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<ul>\r\n \t<li><a href=\"http:\/\/www.fda.gov\/downloads\/RegulatoryInformation\/Guidances\/UCM127067.pdf\">Frequently Asked Questions About Medical Devices<\/a><\/li>\r\n \t<li><a href=\"http:\/\/www.fda.gov\/downloads\/RegulatoryInformation\/Guidances\/UCM126418.pdf\">Significant Risk and Nonsignificant Risk Medical Device Studies<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/clinical-decision-support-software\">Clinical Decision Support Software<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/artificial-intelligence-enabled-device-software-functions-lifecycle-management-and-marketing\">Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations<\/a> (DRAFT 01\/2025)<\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence\">Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions<\/a><\/li>\r\n<\/ul>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"FDA Operations","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<ul>\r\n \t<li><a href=\"http:\/\/www.fda.gov\/downloads\/RegulatoryInformation\/Guidances\/UCM126555.pdf\">FDA Institutional Review Board Inspections<\/a><\/li>\r\n \t<li><a href=\"http:\/\/www.fda.gov\/downloads\/RegulatoryInformation\/Guidances\/UCM126553.pdf\">FDA Inspections of Clinical Investigators<\/a><\/li>\r\n \t<li><a href=\"http:\/\/www.fda.gov\/downloads\/RegulatoryInformation\/Guidances\/UCM214008.pdf\">Clinical Investigator Administrative Actions - Disqualification<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/medical-devices\/digital-health-center-excellence\/device-software-functions-including-mobile-medical-applications\">Device Software Functions Including Mobile Medical Applications<\/a><\/li>\r\n<\/ul>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null}],"update_notice_type":[],"update_notice_start":"2020-11-02 12:30:00","update_notice_end":"2020-11-16 14:00:00","update_notice_text_blocks":[{"update_notice_text":"<p>The title of this page, comprising links to FDA guidance documents, was updated. A few URLs were updated. No other udates were made.<\/p>"}],"global_contact_block":false,"contact_name":"","contact_email":"","contact_additional_info":"Contact us at\u00a0<a href=\"mailto:irbmed@umich.edu\">irbmed@umich.edu<\/a>\u00a0or 734-763-4768 \/ (Fax 734-763-1234)\r\n\r\n2800 Plymouth Road, Ann Arbor, MI 48109-2800\r\n\r\nA <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-contacts-roster#irbmed-staff\">list of IRBMED staff<\/a> is available at our website.\r\n\r\nEdited By: <a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: April 29, 2026 10:00AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/776","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/document"}],"version-history":[{"count":2,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/776\/revisions"}],"predecessor-version":[{"id":2001,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/776\/revisions\/2001"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/884"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/872"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/763"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=776"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=776"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=776"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=776"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=776"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=776"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}