§820.7. Incorporation by reference. — Inbound Citations

(1) If the combination product includes a device constituent part and a drug constituent part, and the current good manufacturing practice operating system has been shown to comply with the drug CGMP requirements or the medical gas CGMP requirements, as applicable, the following clauses of ISO 13485 (together with the definitions in Clause 3 of ISO 9000), which is incorporated by reference into the QMSR under § 820.7 of this chapter, and certain other provisions within the QMSR must also be shown to have been satisfied; upon demonstration that these requirements have been satisfied, no additional showing of compliance with respect to the QMSR need be made:

(i) Clause 4.1, Clause 5 and its subclauses, Clause 6.1 of ISO 13485, and § 820.10 of this chapter;

(ii) Clause 7.3 and its subclauses of ISO 13485. The organization shall document one or more processes for risk management in product realization. Records of risk management activities shall be maintained;

(iii) Clause 7.4. and its subclauses of ISO 13485;

(iv) Clause 8.2.2 and § 820.35(a) of this chapter, Clause 8.4, and Clause 8.5. and its subclauses of ISO 13485;

(v) Clause 7.5.3 of ISO 13485; and

(vi) Clause 7.5.4 of ISO 13485 and § 820.35(b) of this chapter.

(b) The QMSR for devices in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise. To the extent that any applicable requirements in this part conflict with requirements in other parts of this chapter, the requirements specifically applicable to the device in question shall supersede the more generally applicable requirements. Moreover, to the extent that any clauses of ISO 13485 (incorporated by reference, see § 820.7) conflict with any provisions of the Federal Food, Drug, and Cosmetic Act and/or its other implementing regulations, the Federal Food, Drug, and Cosmetic Act and/or its other implementing regulations will control.

(a) 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

The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see § 820.7) apply to this part, except as specified in paragraph (b) of this section, and do not affect the meaning of similar terms defined in this title.

In addition to the requirements of Clause 4.2.5 in ISO 13485 (incorporated by reference, see § 820.7), Control of Records, the manufacturer must include the following information in certain records:

In addition to the requirements of Clause 7.5.1 of ISO 13485 (incorporated by reference, see § 820.7), Control of production and service provision, each manufacturer must document and maintain procedures that provide a detailed description of the activities to ensure the integrity, inspection, storage, and operations for labeling and packaging, during the customary conditions of processing, storage, handling, distribution, and, as appropriate, use of the device.