Delphi Consulting Group (DCG)
An Internet based medical device regulatory service company.
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Delphi Consulting Group (DCG) An Internet based medical device regulatory service company.
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Regulatory Assistance with medical devices and the U.S. FDA.
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This page will post new information from and about the FDA and ISO that may have an impact on your business and some basic FAQs. The FDA has been reviewing the 513(g) and Pre-IDE request procedures for a way to make it all simpler. At present when a FDA 513(g) reply is received they [FDA], ask for a Pre-IDE request that is somewhat the same thing. Some rumors are that the Pre-IDE will be removed from the system, however, at this time [May 2010], this is unknown. The Agency has released two documents, for comment, that update the 513(g) process. One is an update of 513(g) Guidance and the other is a update of the User Fees for 513(g) request. The majority of 513(g) requests received by the FDA request guidance to submit a 510(k) for a device that does the same thing as a released to market device but utilizes different technology. The two 513(g) documents are:
Pathway to market for a new medical Device -- A large number of "new" devices seeking U.S. FDA release to the U.S. market contain new to the FDA and medical application technology. This makes decision regarding what regulatory Class will a given new device be placed in and thus what are the total testing requirements. Click Here for a diagram that details the pathways to market for a new device. Click Here for the FDA overview of the different pathways to market.
The FDA has released a new Guidance document that has major impact on 510(k) submissions. It is titled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]." Click here for a copy. Two industry supplied documents of interest -- regarding Off Label Medical device use are:
Home Use Devices ---- FDA recently issued a white paper revealing that the Agency intends to strengthen its review of medical devices for home use, such as hemodialysis equipment, wound therapy care, intravenous therapy devices, and ventilators, as more hospital patients are being discharged to continue treatment at home. FDA claims that about “7.6 million individuals in the United States currently receive home healthcare from roughly 17,000 paid providers” with annual U.S. expenditures for home care estimated as high as $57.6 billion in 2007. Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health, stated that “[u]sing complex medical devices at home carries unique challenges … Caregivers may lack sufficient training, product instructions may be inadequate or overly technical, and the home environment itself may pose environmental or safety hazards that can affect the product’s functioning. Click on "white paper" in the first sentence for a complete copy of this document.
What happens to an Adverse Event Report (MDR) submitted to the FDA. This is a necessary reporting need, however, very much mis-understood by all parties. See Chart.
FDA's new Transparency Initiative has produced a lot of smoke and some fire. Here is one of the more recent documents released that reviews the process. Click here for the complete document.
Legal -- A comprehensive review of Copyright Issues on the Internet. Click here for the document.
NEW FDA User Fees for FY 2012. Click here for PDF document.
NEW FY 2012 Medical Device User Fee Small Business Qualification and Certification. Click Here for the document in pdf.
NEW & Important Addition of URLs to Electronic Product Labeling and 21 CFR 1010.3 - Identification. Click Here for the documents.
NEW Glimpse of the Future for 510(k) Submission by Nancy J. Stark, Ph.D. Very interesting. Click Here for the document.
NEW New FCC medical program experimental radio license to speed up development of wireless medical devices. Click Here for the document.
NEW Device Unique Device Identifier System report of FDA Pilot Actives. Click Here for the document.
NEW Update to De Novo Classification Process (Evaluation of Automatic Class III Designation). Click Here for the document in pdf. Q - Does the FDA have a set of forms that can be completed to release to market a device that is a Class II, (Special controls) submission? A - NO. Each medical device will have a unique Product Classification, and Product Code that shall detail the performance testing required. The device will have a stated Indication for Use that details what is does for the patient. Each 510(k) submission will have 20 or 21 sections as detailed in Format for Traditional and Abbreviated 510(k)s. For a copy of this FDA Guidance Document click here. Caution Note: This Guidance provides only the top level of requirements and completeness of data required. A 510(k) submission requires an experienced regulatory person to produce a submission that will be found to be Substantially Equivalent, and thus, will release the device to market. Q -- Can a company ready to make a submission on a new medical device choose Class III to provide market protection? A NO -- Each type of device has a Classification under Title 21 Food and Drugs Chapter I - Food and Drug Administration Department of Health and Human Services Subchapter H - Medical Devices. A given classification will dictate Class I, II or III. The FDA will only accept release to market submission that written to the proper Class. Q - Is FDA CFR 21 Part 820 and ISO 9001 the same? A - Yes/No. Their is some relationship between the two Standards however, there are also major differences. See Relationship between FDA's Quality System Regulation for Devices, Part 820 and ISO 9001." Q -- Must medical device clinical studies be completed in the U.S. A -- NO. The FDA will accept clinical studies completed in foreign countries. See Guidance "Acceptance of Foreign Clinical Studies."
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harvey@delphiconsulting.com with
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This page will always be under
construction. Check back often to review new information.
