{"data":{"id":"us/21-cfr-886.5600","jurisdiction":"us","citation":"21 CFR 886.5600","heading":"Ptosis crutch.","body":"(a) Identification. A ptosis crutch is a device intended to be mounted on the spectacles of a patient who has ptosis (drooping of the upper eyelid as a result of faulty development or paralysis) to hold the upper eyelid open.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 886—OPHTHALMIC DEVICES","Subpart F—Therapeutic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"77ce34c73cc141cd83a890de7647048d2bbea6273c5ca95105f7e58027329ed1","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-886.5540","next":"us/21-cfr-886.5700"},"notice":"GroundRules: Original legal text. Not legal advice."}