§812.3. Definitions. — Inbound Citations

(5) A custom device within the meaning of § 812.3(b) of this chapter.

(7) A custom device as defined in § 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(i) For an investigation of a significant risk device, as defined in § 812.3(m), the supporting information as described in paragraph (b) of this section is submitted.

(7) The name and address of the IEC that reviewed the investigation and a statement that the IEC meets the definition in § 812.3(t). The sponsor or applicant must maintain records supporting such statement, including records describing the qualifications of IEC members, and make these records available for agency review upon request;