One of my clients just received the same letter. So I had to dive into the 314 pages of the regulation. In case it's of use to the Forum, here is what I found:
Accept for the licensing requirements (Chapter 102 spanning pp. 1-12 of the document), the DC regulations are basically a local (DC) adoption of medical device laws and regulations that already exist at the federal level. In other words, the content on pp. 13-314 is essentially a recitation of certain preexisting FDA medical device laws and regulations (see p. 2).
However there are some administrative adaptations [such as DC Department of Health (DOH) mailing addresses] to accommodate correspondence with the DC DOH instead of FDA. Beware also that the DC DOH's recitations of FDA's rules/regulations don't always match FDA's current rules/regulations. For example, the Quality System Regulation citations (chapter 107) are from an older version of the Quality System Regulation. Another example: The Establishment Registrations are to be done using the old form FDA-2891 (FDA has since implemented the FURLS system instead).
To sum it all up:
- Comply with the licensing requirements on pp. 1-12.
- Keep complying as usual with the p. 2 FDA rules/regulations, except also send duplicates to the DC DOH too. This even includes things like MDR reports and premarket submissions such as 510(k)s, PMAs, and IDEs.
For the premarket submissions, the DC DOH claims (for example, see subchapter 10521) it will perform a premarket review and clearance that is essentially identical / redundant to FDA's. I don't see how the DC DOH has the bandwidth and capability to duplicate FDA's efforts unless it is via some kind of internal mutual recognition arrangement between the DC DOH and their friends down the road at the FDA.
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Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.comCopyright 2017 by ComplianceAcuity. All rights reserved.
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Original Message:
Sent: 06-Jul-2017 16:46
From: Susan Hamann
Subject: District of Columbia Medical Device Regulations
One of my clients just received a letter from the Health Regulation and Licensing Administration of the Department of Health in DC. I have not heard of this before so we're wondering if it's for real. Hoping someone can help.
Dear Madam/Sir
As of October 28, 2016, the District of Columbia Medical Device Regulations, Title 22-B (Public Health and Medicine), Chapter 102 (Licensing of Medical Devices - Distributors, Manufacturers, Initial Importers, And Vendors) requires that each person engaged in distributing, manufacturing, importing, or the vending of medical devices to or within the District of Columbia must be licensed with the D.C. Department of Health (DOH). For further details, please review or regulations located at .....
The initial license fee is five hundred dollars ($500). The expiration date of the license is September 30th of each year at the cost of five hundred dollars ($500).
The letter goes on but I think you get the idea. Can you provide insight?
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Susan Hamann RAC
President
Hamann QR Consulting
Burlington MA
United States
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