21 CFR 820.10: Requirements for a quality management system

A manufacturer subject to this part as described by § 820.1(a) must:

(a)Document. Document a quality management system that complies with the applicable requirements of ISO 13485 (incorporated by reference, see § 820.7) and other applicable requirements of this part; and

(b)Applicable regulatory requirements. Comply, as appropriate, with the other applicable regulatory requirements in this title, including, but not limited to the following, to fully comply with the listed ISO 13485 Clause:

(1)For Clause 7.5.8 in ISO 13485, Identification, the manufacturer must document a system to assign unique device identification to the medical device in accordance with the requirements of part 830 of this chapter.

(2)For Clause 7.5.9.1 in ISO 13485, Traceability—General, the manufacturer must document procedures for traceability in accordance with the requirements of part 821 of this chapter, if applicable.

(3)For Clause 8.2.3 in ISO 13485, Reporting to regulatory authorities, the manufacturer must notify FDA of complaints that meet the reporting criteria of part 803 of this chapter.

(4)For Clauses 7.2.3, 8.2.3, and 8.3.3, advisory notices shall be handled in accordance with the requirements of part 806 of this chapter.

(c)Design and development. Manufacturers of class II, class III, and those class I devices listed in paragraph (c)(1) of this section and table 1 to paragraph (c)(2) of this section must comply with the requirements in Design and Development, Clause 7.3 and its Subclauses in ISO 13485. The class I devices are as follows:

(1)Devices automated with computer software; and

(2)The devices listed in the following table:

Table 1 to Paragraph (c)(2)

Section

Device

868.6810

Catheter, Tracheobronchial Suction.

878.4460

Glove, Non-powdered Surgeon's.

880.6760

Restraint, Protective.

892.5650

System, Applicator, Radionuclide, Manual.

892.5740

Source, Radionuclide Teletherapy.

(d)Devices that support or sustain life. Manufacturers of devices that support or sustain life, the failure of which to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury, must comply with the requirements in Traceability for Implantable Devices, Clause 7.5.9.2 in ISO 13485, in addition to all other applicable requirements in this part, as appropriate.

(e)Enforcement. The failure to comply with any applicable requirement in this part renders a device adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.