The following questions and answers offer guidance to healthcare facilities working to comply with the new MDDS rule:When is a healthcare facility considered an MDDS manufacturer?If a healthcare facility creates an MDDS, then the FDA will consider the healthcare facility a device manufacturer, and that healthcare facility must do all the things that device manufacturers are required to do.What must a healthcare facility do if it is an MDDS manufacturer?Register with the FDA, list its MDDS products, report adverse events, and comply with FDA's Quality Systems regulation.Does it matter if a healthcare facility sells the MDDS or not?“Sell” is not the term that we use for determining whether something falls under FDA jurisdiction. The question is if something has been put into commercial distribution, which could mean being put into use on a patient. It doesn't matter if there is an exchange of money.What about devices that are just being developed?Pilot devices that are not in live use are in the same category as devices under development, not in active clinical use. So you don't have to register and list the products until they are put “on the market” which, in the hospital setting, is in actual clinical practice.Does this rule make a healthcare facility a medical device manufacturer if it makes some other type of medical device, and would it have to file a 510(k)?Anyone who makes a medical device is a medical device manufacturer, except in the certain conditions where they have exemptions for custom devices made by one physician to be used in his or her practice. There is a special regulation for that. If you're making something for hospital use that's going beyond the custom use, you should give us a call, so we can talk about it. If you make a medical device, you're a manufacturer, and that's really beyond the MDDS rule. That's just general regulatory practice.How often and when should hospitals that are registered with listed MDDS systems be inspected by FDA investigators?Although in a perfect world an establishment might be inspected every two years, in reality it is a risk-based approach. Therefore, the FDA inspects device establishments on a periodic basis. The selection of an establishment is determined using a risk-based approach (e.g., addressing a public health situation or based on product classification). The FDA has determined that MDDS devices, when design controls and quality systems have been applied appropriately, are relatively low risk, so the inspection schedule is designed accordingly.Is 14971a an appropriate risk management tool, or IEC 80001-1?bYou need to look at both of them and apply them appropriately. 80001 refers to 14971 as a normative standard, so if you follow 80001, you're covering 14971 as well, I believe. 80001 is a very good document to examine.When you are inspecting hospitals, what is the information you are looking for besides the MDDS they implemented?Essentially, we are looking at the documents in a quality system. We're not going to be looking at the MDDS per se. We will look at the document that describes the system. Is it adequately described? Does it look like all the elements of a quality system are in place?Do you have any advice for hospitals that need to comply with this rule?Refer to our website, and to the rule itself. Basically, you have to register and list your devices. That tells us that you're out there and that you make a product. Then, you have to build a quality system. You have a whole year to come up to speed on quality systems. When you're thinking about a quality system, I would just say don't assume that you have to re-create new stuff. Start from where you are. Most folks, we hope, have at least started something to track the system they have. Start with that and build on it to come up with a quality system.Is there a working group with FDA and AAMI or anyone else to help clarify quality management system requirements for healthcare organizations?When the rule first went out, we did have a “high level briefing” of American Hospital Association (AHA) folks. There weren't a lot of people on that call. The FDA held a webinar with AHA on June 30, 2011. AAMI held a webinar in June 2011 and also sessions on the MDDS rule at its 2011 Annual Conference.