1. Regulations
  2. title 21
  3. chapter I-i7
  4. part 820
  5. subpart A
  6. § 820.5

View all text of Subpart A [§ 820.1 - § 820.5]

§ 820.5 - Quality system.

Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.

AUTHORITY: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

SOURCE: 61 FR 52654, Oct. 7, 1996, unless otherwise noted.

CITE AS: 21 CFR 820.5