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REGULATORY AND QUALITY

US Regulatory Services

Donawa Lifescience Consulting (DLC) has more than 25 years’ experience in dealing with various aspects of the US Food and Drug Administration (FDA) regulatory system. We can work with you from the beginning with assistance for registering your facility and listing your products, through to developing pre-market submissions, and dealing with any post-market issues that may arise.

Registration and Listing

Companies that are involved in the production and distribution of medical devices that are intended for marketing in the US are required to register their facility on-line with the FDA. There is a fee for registering applicable facilities, which changes annually. Facility registrations and device listing must be carried out between 1 October and 31 December to be valid for the following year. DLC is ready to assist with any registration and listing questions you may have.

Pre-Market Submissions

Depending on perceived clinical risk of use, the FDA places medical devices into one of three classes: Class I, Class II and Class III (highest risk). In general terms, Class I devices do not require premarket clearance, while Class II devices generally go through the 510(k) route (Traditional, Abbreviated or Special), and Class III devices require specific pre-market approval (PMA). In addition, medium risk devices utilising novel technology may be cleared via the de novo 510(k) route. FDA also recommends that for all but the most straightforward submissions, use is made of the FDA’s ‘Pre-Sub’ route, by which means manufacturers can obtain ‘free’ advice from the agency before committing to extensive clinical studies or bench tests. FDA charges fees for the other types of submission reviews which change on an annual basis. DLC is able to help clients develop documentation suitable for each of these submission types, maintaining contact with the agency until the device achieves market clearance.

Medical Device Reporting

The Medical Device Reporting (MDR) Regulation (21 CFR 803) requires that all manufacturers report to FDA whenever a device:

  • may have caused or contributed to a death or serious injury or
  • has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur

DLC can assist you in deciding what is required to be reported and how soon it is required to be reported, as well as how the information should be submitted. Currently, it is mandatory to submit ‘eMDR’ reports via the US Electronic Submissions Gateway (ESG). We can also assist you in developing, maintaining, and implementing written MDR procedures for your company.

Corrections and Removals

When a company needs to carry out field activities to recall or modify devices or their labeling for safety reasons, they must notify the FDA, in accordance with 21 CFR 806, ‘Corrections and Removals’. DLC can help you understand what is required by the regulation and assist in the following steps necessary to meet requirements:

  • plan to contact the customers who received the device
  • supply information to help users identify the device and take steps to minimize any health consequences
  • work with you and FDA to obtain information about the product, the problem, the correction or removal strategy, and the steps that need to be taken to prevent recurrence
  • conduct a pre-audit to make sure that the corrective action plans and efforts are appropriate and effective
  • prepare periodic status reports for filing with FDA.

To discuss any of the DLC services related to US regulatory requirements, please contact us to see how we may be able to help.

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