10625. TIME FRAMES FOR REVIEWING A HUMANITARIAN DEVICE EXEMPTION

10625 TIME FRAMES FOR REVIEWING A HUMANITARIAN DEVICE EXEMPTION 10625.1 Within seventy-five (75) days after receipt of an HDE that is accepted for filing and to which the applicant does not submit a major amendment, the Department will send the applicant an approval order, an approvable letter, a not approvable letter (under § 10626), or an order denying approval (under § 10627). SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10625