Current through July 31, 2024
Section 807.90 - Format of a premarket notification submissionEach premarket notification submission pursuant to this part shall be submitted in accordance with this section. Each submission shall:
(a)(3) All inquiries regarding a premarket notification submission should be sent to the address in this section or one of the current addresses displayed on the Food and Drug Administration's website.(c) Be submitted as a single version in electronic format.(d) Be submitted separately for each product the manufacturer intends to market.(e) Designated "510(k) Notification" in the cover letter.42 FR 42526, Aug. 23, 1977, as amended at 53 FR 11252, Apr. 6, 1988; 55 FR 11169, Mar. 27, 1990; 65 FR 17137, Mar. 31, 2000; 70 FR 14986, Mar. 24, 2005; 75 FR 20915, Apr. 22, 2010; 80 FR 18094, Apr. 3, 2015; 84 FR 68339, Dec. 16, 2019