{"data":{"id":"us/21-cfr-814.114","jurisdiction":"us","citation":"21 CFR 814.114","heading":"Timeframes for reviewing an HDE.","body":"Within 75 days after receipt of an HDE that is accepted for filing and to which the applicant does not submit a major amendment, FDA shall send the applicant an approval order, an approvable letter, a not approvable letter (under § 814.116), or an order denying approval (under § 814.118).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES","Subpart H—Humanitarian Use 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":"aec5f41e06e26333a6135532d3794edc4ba7d8e5817d66311f2aca8b681ab865","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-814.112","next":"us/21-cfr-814.116"},"notice":"GroundRules: Original legal text. Not legal advice."}