FDA 医疗器械法规 CFR-2021-title21-vol8-part820.pdf

Pt. 820 21 CFR Ch. I (4–1–21 Edition) reasonably should be known to the ap- Subpart E—Purchasing Controls plicant, medical device reports made under part 803 of this chapter, any data 820.50 Purchasing controls. generated from the postmarketing Subpart F—Identification and Traceability studies, and information (whether pub- lished or unpublished) that is known or 820.60 Identification. reasonably expected to be known by 820.65 Traceability. the applicant that may affect an eval- uation of the safety of the device or Subpart G—Production and Process that may affect the statement of con- Controls traindications, warnings, precautions, 820.70 Production and process controls. and adverse reactions in the device’s 820.72 Inspection, measuring, and test labeling; and equipment. (v) A summary of any changes made