id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2016-N-1111-1838,FDA,FDA-2016-N-1111,Medical Devices; Petition for an Administrative Stay of Action: Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Rule,Final Rule,2020-08-19T04:00:00Z,2020,8,2020-08-19T04:00:00Z,,2020-08-19T12:54:34Z,2020-16595,0,0,09000064848104bf
FDA-2016-N-1111-1762,FDA,FDA-2016-N-1111,Reference 21 - Investigation Report re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:22:15Z,,0,0,09000064843fd66e
FDA-2016-N-1111-1754,FDA,FDA-2016-N-1111,Reference 11 - A review of behavioral treatments for self-injurious behaviors of persons with autism spectrum disorders re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:19:42Z,,0,0,09000064843fd571
FDA-2016-N-1111-1822,FDA,FDA-2016-N-1111,Reference 86 - DOJ Letter to Neurological Devices Panel re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:58:53Z,,0,0,09000064843fd4d2
FDA-2016-N-1111-1758,FDA,FDA-2016-N-1111,Reference 17 - A quasi-experimental study on the effect of electrical aversion treatment on imposed mechanical restraint for self-injurious behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:20:55Z,,0,0,09000064843fd575
FDA-2016-N-1111-1749,FDA,FDA-2016-N-1111,Reference 6 - FDA Aversive Conditioning Panel Presentation re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:18:22Z,,0,0,09000064843fcb87
FDA-2016-N-1111-1759,FDA,FDA-2016-N-1111,Reference 18 - Therapeutic shock device - Clinical evaluation with SIBs re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:21:09Z,,0,0,09000064843fd576
FDA-2016-N-1111-1778,FDA,FDA-2016-N-1111,Reference 39 - Developing function-based punishment procedures for problem behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:26:46Z,,0,0,09000064843fd680
FDA-2016-N-1111-1792,FDA,FDA-2016-N-1111,Reference 55 - Remotely applied punishment vs avoidance conditioning in the treatment of SIBs re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:31:33Z,,0,0,09000064843fd698
FDA-2016-N-1111-1783,FDA,FDA-2016-N-1111,Reference 46 - Social policy on the use of aversive interventions re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:28:22Z,,0,0,09000064843fd68f
FDA-2016-N-1111-1776,FDA,FDA-2016-N-1111,Reference 37 - Elimination of Chronic Cough by Response Suppression Shaping re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:26:15Z,,0,0,09000064843fd67e
FDA-2016-N-1111-1763,FDA,FDA-2016-N-1111,Reference 22 - Observations and Findings of Out-of-State Program Visitation re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:22:30Z,,0,0,09000064843fd66f
FDA-2016-N-1111-1777,FDA,FDA-2016-N-1111,"Reference 38 - Punishment in behavior modification - Practical, ethical, and legal issues re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior",Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:26:31Z,,0,0,09000064843fd67f
FDA-2016-N-1111-1786,FDA,FDA-2016-N-1111,"Reference 49 - Behavioral contingencies, self-mutilation in Lesch-Nyhan disease re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior",Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:29:31Z,,0,0,09000064843fd692
FDA-2016-N-1111-1815,FDA,FDA-2016-N-1111,Reference 79 - ECT for self-injury in an autistic boy re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:38:59Z,,0,0,09000064843fd4b8
FDA-2016-N-1111-1798,FDA,FDA-2016-N-1111,Reference 61 - Long-term use of electrical aversion treatment with SIB re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:33:26Z,,0,0,09000064843fd69e
FDA-2016-N-1111-1820,FDA,FDA-2016-N-1111,Reference 84 - Response to Testimony and Written Comments re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:58:08Z,,0,0,09000064843fd4d0
FDA-2016-N-1111-1752,FDA,FDA-2016-N-1111,Reference 9 - Toward a technology of 'nonaversive' behavioral support re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:19:09Z,,0,0,09000064843fcb8a
FDA-2016-N-1111-1775,FDA,FDA-2016-N-1111,Reference 36 - Common behavioral decelerators (aversives) and their efficacy re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:25:53Z,,0,0,09000064843fd67d
FDA-2016-N-1111-1790,FDA,FDA-2016-N-1111,Reference 53 - The right to aversive treatment including aversive stimuli re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:31:00Z,,0,0,09000064843fd696
FDA-2016-N-1111-1828,FDA,FDA-2016-N-1111,Reference 93 - A quantitative examination of punishment research re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T13:01:06Z,,0,0,09000064843fd4d9
FDA-2016-N-1111-1832,FDA,FDA-2016-N-1111,Reference 98 - Psychiatric and cognitive aspects of PKU - The limitations and promise of new treatments re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T13:02:39Z,,0,0,09000064843fd4dd
FDA-2016-N-1111-1811,FDA,FDA-2016-N-1111,Reference 75 - 30 years of research on functional analysis of problem behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:37:44Z,,0,0,09000064843fd4b4
FDA-2016-N-1111-1814,FDA,FDA-2016-N-1111,Reference 78 - SIB in neurodevelopmental disorders - Relevance of nociceptive and immune mechanisms re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:38:38Z,,0,0,09000064843fd4b7
FDA-2016-N-1111-1816,FDA,FDA-2016-N-1111,Reference 80 - Adapted Dialectical Behavior Therapy for Adolescents with Self-Injurious Thoughts and Behaviors re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:39:25Z,,0,0,09000064843fd4b9
FDA-2016-N-1111-1779,FDA,FDA-2016-N-1111,Reference 40 - Use of punishment procedures re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:27:10Z,,0,0,09000064843fd681
FDA-2016-N-1111-1747,FDA,FDA-2016-N-1111,Reference 4 - Panel Meeting Roster re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:17:47Z,,0,0,09000064843fc934
FDA-2016-N-1111-1750,FDA,FDA-2016-N-1111,Reference 7 - Side effects of contingent shock treatment re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:18:39Z,,0,0,09000064843fcb88
FDA-2016-N-1111-1756,FDA,FDA-2016-N-1111,Reference 15 - Panel Meeting Transcript re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:20:16Z,,0,0,09000064843fd573
FDA-2016-N-1111-1810,FDA,FDA-2016-N-1111,Reference 74 - Functional analysis of problem behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:37:20Z,,0,0,09000064843fd4b3
FDA-2016-N-1111-1812,FDA,FDA-2016-N-1111,Reference 76 - View on the efficacy and ethics of punishment re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:38:00Z,,0,0,09000064843fd4b5
FDA-2016-N-1111-1793,FDA,FDA-2016-N-1111,Reference 56 - Punishment as a therapeutic method with institutionalized persons re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:31:49Z,,0,0,09000064843fd699
FDA-2016-N-1111-1831,FDA,FDA-2016-N-1111,Reference 97 - Pharmacological treatment of severe irritability and problem behaviors in autism re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T13:02:14Z,,0,0,09000064843fd4dc
FDA-2016-N-1111-1772,FDA,FDA-2016-N-1111,Reference 33 - Use of aversive stimulation in behavior modification re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:25:05Z,,0,0,09000064843fd67a
FDA-2016-N-1111-1753,FDA,FDA-2016-N-1111,Reference 10 - Efficacy of behavioral interventions for reducing problem behavior in persons with autism re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:19:24Z,,0,0,09000064843fd570
FDA-2016-N-1111-1796,FDA,FDA-2016-N-1111,Reference 59 - Punishment (Positive Punishment) re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:32:51Z,,0,0,09000064843fd69c
FDA-2016-N-1111-1746,FDA,FDA-2016-N-1111,Reference 3 - Self-injury among a community cohort of young children re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:17:29Z,,0,0,09000064843fc933
FDA-2016-N-1111-1768,FDA,FDA-2016-N-1111,Reference 28 - DSM-5 - PTSD re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:23:54Z,,0,0,09000064843fd674
FDA-2016-N-1111-1785,FDA,FDA-2016-N-1111,Reference 48 - Modification of schizophrenic behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:29:08Z,,0,0,09000064843fd691
FDA-2016-N-1111-1782,FDA,FDA-2016-N-1111,Reference 45 - On the importance of reliable equipment in the shock punishment of SIB re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:27:57Z,,0,0,09000064843fd68e
FDA-2016-N-1111-1835,FDA,FDA-2016-N-1111,RIA Reference 1-3 - NAICS 623220 wages (May 2018) re PRIA Reference 3 Proposed Regulatory Impact (Economic) Analysis (PRIA) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T13:04:20Z,,0,0,09000064843fd4e0
FDA-2016-N-1111-1802,FDA,FDA-2016-N-1111,Reference 65 - Positive behavioral support of adults with developmental disabilities re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:34:41Z,,0,0,09000064843fd6a3
FDA-2016-N-1111-1803,FDA,FDA-2016-N-1111,Reference 66 - Manipulation of self-destruction in three children re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:34:58Z,,0,0,09000064843fd6a4
FDA-2016-N-1111-1799,FDA,FDA-2016-N-1111,Reference 62 - A maintenance strategy for discontinuing aversive procedures re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:33:47Z,,0,0,09000064843fd69f
FDA-2016-N-1111-1801,FDA,FDA-2016-N-1111,Reference 64 - Are aversive procedures durable re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:34:22Z,,0,0,09000064843fd6a2
FDA-2016-N-1111-1821,FDA,FDA-2016-N-1111,Reference 85 - Ellen Howe affidavit re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:58:28Z,,0,0,09000064843fd4d1
FDA-2016-N-1111-1780,FDA,FDA-2016-N-1111,Reference 42 - Aversion for the treatment of SIB re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:27:25Z,,0,0,09000064843fd682
FDA-2016-N-1111-1787,FDA,FDA-2016-N-1111,Reference 50 - Control of chronic SIB by conditioning procedures re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:29:48Z,,0,0,09000064843fd693
FDA-2016-N-1111-1761,FDA,FDA-2016-N-1111,Reference 20 - A 4-year follow-up of treatment of self-injury re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:21:43Z,,0,0,09000064843fd66d
FDA-2016-N-1111-1817,FDA,FDA-2016-N-1111,Reference 81 - Do improvements after inpatient dialectical behavioral therapy persist in the long term re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:39:46Z,,0,0,09000064843fd4ba
FDA-2016-N-1111-1788,FDA,FDA-2016-N-1111,Reference 51 - Remission of chronic ruminative vomiting through a reversal of social contingencies re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:30:06Z,,0,0,09000064843fd694
FDA-2016-N-1111-1833,FDA,FDA-2016-N-1111,RIA Reference 1-1 - NAICS 623000 wages (May 2018) re PRIA Reference 3 Proposed Regulatory Impact (Economic) Analysis (PRIA) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T13:03:15Z,,0,0,09000064843fd4de
FDA-2016-N-1111-1836,FDA,FDA-2016-N-1111,RIA Reference 3 - Treating Challenging Behaviors with DBT re PRIA Reference 3 Proposed Regulatory Impact (Economic) Analysis (PRIA) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T13:05:10Z,,0,0,09000064843fd4e1
FDA-2016-N-1111-1800,FDA,FDA-2016-N-1111,Reference 63 - A comparison of shock intensity in the treatment of longstanding and severe SIB re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:34:05Z,,0,0,09000064843fd6a0
FDA-2016-N-1111-1809,FDA,FDA-2016-N-1111,Reference 73 - Punishment by Stimulus Presentation re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:36:54Z,,0,0,09000064843fd6aa
FDA-2016-N-1111-1804,FDA,FDA-2016-N-1111,Reference 67 - Seven case studies of individuals expelled from positive-only programs re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:35:19Z,,0,0,09000064843fd6a5
FDA-2016-N-1111-1823,FDA,FDA-2016-N-1111,Reference 87 - Positive Behavior Support for People with Developmental Disabilities re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:59:16Z,,0,0,09000064843fd4d3
FDA-2016-N-1111-1824,FDA,FDA-2016-N-1111,Reference 88 - Positive behavior support and applied behavior analysis - A familial alliance re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:59:34Z,,0,0,09000064843fd4d4
FDA-2016-N-1111-1789,FDA,FDA-2016-N-1111,Reference 52 - Extinction procedure for eliminating SIB in a 9-year old autistic girl re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:30:33Z,,0,0,09000064843fd695
FDA-2016-N-1111-1834,FDA,FDA-2016-N-1111,RIA Reference 1-2 - NAICS 623210 wages (May 2018) PRIA Reference 3 Proposed Regulatory Impact (Economic) Analysis (PRIA) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T13:03:41Z,,0,0,09000064843fd4df
FDA-2016-N-1111-1784,FDA,FDA-2016-N-1111,Reference 47 - Treatment of aggression with behavioral programming that includes supplementary contingent skin shock re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:28:49Z,,0,0,09000064843fd690
FDA-2016-N-1111-1744,FDA,FDA-2016-N-1111,List of References re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:15:57Z,,0,0,09000064843fc931
FDA-2016-N-1111-1751,FDA,FDA-2016-N-1111,Reference 8 - The efficacy of positive behavioural support with the most challenging behaviour re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:18:53Z,,0,0,09000064843fcb89
FDA-2016-N-1111-1795,FDA,FDA-2016-N-1111,Reference 58 - The successful treatment of a dually-diagnosed deaf man's aggression with a program that included contingent electric shock re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:32:33Z,,0,0,09000064843fd69b
FDA-2016-N-1111-1813,FDA,FDA-2016-N-1111,Reference 77 - SIB in children with developmental disabilities re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:38:20Z,,0,0,09000064843fd4b6
FDA-2016-N-1111-1826,FDA,FDA-2016-N-1111,Reference 91 - Personal Paradigm Shifts Among ABA and PBS Experts re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T13:00:25Z,,0,0,09000064843fd4d6
FDA-2016-N-1111-1760,FDA,FDA-2016-N-1111,Reference 19 - A long-term follow-up of treatment for severe self-injury re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:21:22Z,,0,0,09000064843fd577
FDA-2016-N-1111-1748,FDA,FDA-2016-N-1111,Reference 5 - Panel Meeting Executive Summary re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:18:04Z,,0,0,09000064843fc935
FDA-2016-N-1111-1755,FDA,FDA-2016-N-1111,Reference 12 - Patients Exhibiting Self-Injurious and Aggressive Behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:20:00Z,,0,0,09000064843fd572
FDA-2016-N-1111-1757,FDA,FDA-2016-N-1111,Reference 16 - An accelerometer-activated device to control assaultive and self-destructive behaviors re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:20:32Z,,0,0,09000064843fd574
FDA-2016-N-1111-1766,FDA,FDA-2016-N-1111,Reference 26 - Posttraumatic stress disorder - An empirical evaluation of core assumptions re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:23:21Z,,0,0,09000064843fd672
FDA-2016-N-1111-1770,FDA,FDA-2016-N-1111,Reference 31 - The control of violent behavior through faradic shock re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:24:31Z,,0,0,09000064843fd676
FDA-2016-N-1111-1805,FDA,FDA-2016-N-1111,Reference 68 - A component analysis of positive behaviour support plans re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:35:45Z,,0,0,09000064843fd6a6
FDA-2016-N-1111-1774,FDA,FDA-2016-N-1111,Reference 35 - Behavior Modification Techniques in the Treatment of SIB in Institutionalized Persons re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:25:38Z,,0,0,09000064843fd67c
FDA-2016-N-1111-1765,FDA,FDA-2016-N-1111,Reference 25 - Building social behavior in autistic children by use of electric shock re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:23:06Z,,0,0,09000064843fd671
FDA-2016-N-1111-1794,FDA,FDA-2016-N-1111,Reference 57 - Life threatening behavior - Analysis and intervention re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:32:08Z,,0,0,09000064843fd69a
FDA-2016-N-1111-1827,FDA,FDA-2016-N-1111,Reference 92 - The path to aversive interventions - Four mothers' perceptions re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T13:00:47Z,,0,0,09000064843fd4d7
FDA-2016-N-1111-1829,FDA,FDA-2016-N-1111,Reference 95 - Assessment and treatment of challenging behaviour for individuals with intellectual disability re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T13:01:28Z,,0,0,09000064843fd4da
FDA-2016-N-1111-1830,FDA,FDA-2016-N-1111,Reference 96 - Association Between SIB and Autism Spectrum Disorders re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T13:01:51Z,,0,0,09000064843fd4db
FDA-2016-N-1111-1797,FDA,FDA-2016-N-1111,Reference 60 - On the status of knowledge for using punishment - Implications for treating behavior disorders re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:33:07Z,,0,0,09000064843fd69d
FDA-2016-N-1111-1825,FDA,FDA-2016-N-1111,Reference 89 - Positive behaviour support for a child with severe learning disability re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:59:58Z,,0,0,09000064843fd4d5
FDA-2016-N-1111-1818,FDA,FDA-2016-N-1111,Reference 82 - Report on the Use and Effects of ESDs re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:57:04Z,,0,0,09000064843fd4ce
FDA-2016-N-1111-1745,FDA,FDA-2016-N-1111,Reference 2 - Should the FDA Ban Aversive Conditioning Devices re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:17:09Z,,0,0,09000064843fc932
FDA-2016-N-1111-1806,FDA,FDA-2016-N-1111,Reference 69 - Fifteen years later - Has positive programming become the expected technology for addressing problem behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:36:02Z,,0,0,09000064843fd6a7
FDA-2016-N-1111-1807,FDA,FDA-2016-N-1111,Reference 70 - The role of positive programming in behavioral treatment re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:36:20Z,,0,0,09000064843fd6a8
FDA-2016-N-1111-1791,FDA,FDA-2016-N-1111,Reference 54 - Effectiveness of several suppression procedures in eliminating high-probability response in a severely brain-damaged child re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:31:16Z,,0,0,09000064843fd697
FDA-2016-N-1111-1837,FDA,FDA-2016-N-1111,RIA Reference 4 - NAICS 2017 Table of Size Standards PRIA Reference 3 Proposed Regulatory Impact (Economic) Analysis (PRIA) re Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T13:05:31Z,,0,0,09000064843fd4e2
FDA-2016-N-1111-1819,FDA,FDA-2016-N-1111,Reference 83 - An evaluation of positive behavioural support for people with very severe challenging behaviours in community-based settings re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:57:20Z,,0,0,09000064843fd4cf
FDA-2016-N-1111-1767,FDA,FDA-2016-N-1111,Reference 27 - Post-traumatic stress disorder without the trauma re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:23:40Z,,0,0,09000064843fd673
FDA-2016-N-1111-1769,FDA,FDA-2016-N-1111,Reference 29 - The use of punishment as a treatment modality re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:24:10Z,,0,0,09000064843fd675
FDA-2016-N-1111-1771,FDA,FDA-2016-N-1111,Reference 32 - The effects of the reinforcement of compatible and incompatible alternative behaviors on self-injurious and related behaviors re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:24:49Z,,0,0,09000064843fd679
FDA-2016-N-1111-1781,FDA,FDA-2016-N-1111,Reference 43 - SIB - A behavioral analysis re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:27:42Z,,0,0,09000064843fd68d
FDA-2016-N-1111-1764,FDA,FDA-2016-N-1111,Reference 24 - Stimulus fading and transfer in the treatment of self-restraint and SIB re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:22:51Z,,0,0,09000064843fd670
FDA-2016-N-1111-1773,FDA,FDA-2016-N-1111,Reference 34 - Overcoming situation-specific problems associated with typical institutional attempts to suppress self-mutialtive behavior re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:25:22Z,,0,0,09000064843fd67b
FDA-2016-N-1111-1808,FDA,FDA-2016-N-1111,"Reference 72 - Explosive, oppositional, and aggressive behavior in children with autism compared to other clinical disorders and typical children re Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior",Supporting & Related Material,Background Material,2020-03-09T04:00:00Z,2020,3,,,2020-03-23T12:36:37Z,,0,0,09000064843fd6a9
FDA-2016-N-1111-1743,FDA,FDA-2016-N-1111,Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior,Rule,Final Rule,2020-03-06T05:00:00Z,2020,3,2020-03-06T05:00:00Z,,2020-03-20T18:30:05Z,2020-04328,0,0,09000064843f9b66
FDA-2016-N-1111-1709,FDA,FDA-2016-N-1111,"Attachment 6 Linked Profile of Quentin Davies re: Supplemental Comment from Eckert Seamans  Judge Rotenberg Educational Center, Inc.",Supporting & Related Material,Background Material,2017-04-11T04:00:00Z,2017,4,,,2017-04-11T13:57:54Z,,0,0,090000648254a525
FDA-2016-N-1111-1706,FDA,FDA-2016-N-1111,"Attachment 3 Article from ASAN ""Tell the FDA: Ban Electric Shock Torture of People with Disabilities"" re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc.",Supporting & Related Material,Background Material,2017-04-11T04:00:00Z,2017,4,,,2017-04-11T13:47:59Z,,0,0,090000648254a522
FDA-2016-N-1111-1707,FDA,FDA-2016-N-1111,"Attachment 4 Article from Change.org ""USA Today: Time to ban skin shocks to disabled"" re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc.",Supporting & Related Material,Background Material,2017-04-11T04:00:00Z,2017,4,,,2017-04-11T13:50:42Z,,0,0,090000648254a523
FDA-2016-N-1111-1716,FDA,FDA-2016-N-1111,"Attachment 13 Instructions for Use Amplatzer PFO Occluder re: Supplemental Comment from Eckert Seamans Judge Rotenberg Educational Center, Inc.",Supporting & Related Material,Background Material,2017-04-11T04:00:00Z,2017,4,,,2017-04-11T14:42:57Z,,0,0,090000648254a53d