FDA Publishes Rule to Require PMA or PDP for Four Class III Preamendment Devices
Written by: Lisa KingWednesday, September 1st, 2010 | FDA Medical Device Regulations | No Comments
On August 25, 2010, the FDA published the proposed rule for the submission of premarket approval applications (PMA) or product development protocols (PDP) for four preamendment Class III medical devices: ventricular bypass (assist) devices; pacemaker repair or replacement materials; female condoms; and transilluminators for breast evaluation.
In April 2009, the FDA first published notice requiring manufacturers of these devices and others, to submit information to allow the agency to evaluate the risk-level of each type of device and determine if the devices should be classified to require the submission of a PMA (maintained in Class III) or down-classified to class I or II. This published proposed rule reviews the product-related risks identified by the FDA as the basis for the proposed Class III classification.
Interested parties may request that the agency change the classification of any of these devices based on new information. Comments to the docket will be accepted until November 23, 2010 and requests for reclassification must be submitted by September 9, 2010.
Industry Slow to Respond to FDA Call for Infusion Pump Assurance Case Reports and Clinical Evaluations
Written by: Cindy NolteTuesday, August 31st, 2010 | FDA Medical Device Regulations | No Comments
In June, we reported on FDA’s Infusion Pump Improvement Initiative. As part of the initiative, FDA issued a draft guidance, Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions, which recommends that medical device companies manufacturing infusion pumps demonstrate substantial equivalence through the use of assurance case reports, in addition to conducting clinical evaluations to evaluate the performance of their medical devices in a “real world” setting.
Yesterday, during an AAMI webinar “Assurance Case Reports – Infusion Pumps” MDCI learned some interesting facts regarding the medical device industry’s response to the new guidance document.
In his introductory remarks, Mr. Richard C. Chapman, BA, MS, Acting Branch Chief, General Hospital Devices Branch at ODE provided some interesting statistics regarding infusion pump 510(k) submissions currently under review. According to Chapman, there are 17 infusion pump 510(k)s currently under review at the FDA. Five of these 510(k)s have been submitted since the TPLC Infusion Pump Guidance was issued on April 23, 2010. Two of these five 510(k)s included safety assurance cases, while none of the 510(k)s included clinical evaluations. Chapman commented that the medical device industry does not seem to be taking the FDA seriously. He went on to say that three clinical evaluation protocols are under review in a pre-IDE setting. Two pre-IDEs for assurance cases were also under review.
Chapman stated that the most challenging submissions are those that were already under review when the FDA issued the draft guidance. He said that while he understands the difficulties the draft guidance presents for these medical device manufacturers, he believes that ultimately safety will win out. This implies that clinical evaluations will likely be required for these devices.
When asked if the FDA was enforcing the infusion pump guidance, even though it is still a draft, Chapman stated that the document represents the FDA’s current thinking regarding the information required to make a substantial equivalence decision for an infusion pump. This suggests to us that the FDA is currently enforcing these requirements and that the adjustments to the guidance when it is final will be made mainly to clarify the requirements, not loosen them.
FDA Update - CDRH Issues Medical Device Recommendations
Written by: Lisa KingFriday, August 6th, 2010 | FDA Medical Device Regulations | No Comments
This week the FDA’s Center for Devices and Radiological Health (CDRH) released two major reports recommending actions the Center could take to change the way it oversees medical devices. The first report provides preliminary recommendations that CDRH will consider to strengthen the 510(k) premarket review process. Highlights include creation of a new device class called “Class IIb” devices, which will require medical equipment manufacturers to provide some form of clinical evidence to prove effectiveness. In addition, the agency indicated that it will issue clarification on its rescission authority to revoke 510(K) clearances for devices they believe have a high safety risk. The CDRH also stated that it will provide evidence clarifying when a device shouldn’t be used as a predicate device, and that it will evaluate the “De Novo” 510(k) process to clarify requirements to allow more consistency in a risk-based approach. This will provide an appropriate level of review and regulatory control for eligible medical devices.
The second report relates to a task force finding regarding CDRH’s use of science in decision making and managing the device approval process as science evolves. A key element of this second report is the creation of a new Center Science Council to guide CDRH in science based decision making. There is no specific timeline yet for implementation of these recommendations, but the FDA has invited public comment. In our recent experience, MDCI has noted an increase in requests for information from CDRH review staff, as well as more scrutiny of 510(k) content, 510(k) summaries and other required forms. In this changing regulatory landscape, it is no longer prudent to assume that the 510(k) strategies which have been used to clear medical devices in the past will be adequate for future submissions.
Q1 Conference in Baltimore Highlights FDA Regulatory Challenges for Combination Products
Written by: Lisa KingMonday, July 19th, 2010 | FDA Medical Device Regulations, Industry News and Innovations, International Medical Device Requirements | No Comments
On July 12-13, 2010, MDCI participated in the Q1 Conference on Combination Products in Baltimore, MD. FDA officials and industry experts participated in presentations and panel discussions to address the regulatory framework and challenges of developing and gaining product approval for combination products or medical therapies that combine two or more regulated components. › Continue reading
FDA Could Tighten Focus on Human Factors Testing for Medical Devices
Written by: MDCI Blogging TeamMonday, July 12th, 2010 | FDA Medical Device Regulations, Industry News and Innovations, Medical Device Clinical Trials | No Comments
Medical device developers are accustomed to the strict demands made by the FDA with regards to the type of clinical efficacy and outcomes data that must be collected prior to a medical device being approved for the American market. However, there is another tier of product testing which is starting to garner more and more attention at the regulatory level - that which relates to a device’s usability by both patients and practitioners. › Continue reading
Trends, Services and Solutions for New Medical Device Companies - Overseas Medical Device Vendor Outsourcing
Written by: MDCI Blogging TeamThursday, July 8th, 2010 | FDA Medical Device Regulations, International Medical Device Requirements, Medical Device Market, Medical Device Quality Assurance | No Comments
This article continues a series regarding the services that MDCI is most often called to provide new medical device start-ups as they navigate towards bringing a treatment successfully to market.
In the medical device community it is not uncommon for start-up companies to explore the possibility of manufacturing their product outside of North America. A brief examination of the potential savings associated with offshore manufacturing makes it easy to understand the appeal of looking to Asia or even some parts of Europe in order to secure an affordable production contract. › Continue reading
Trends, Services and Solutions for New Medical Device Companies - Avoiding the ‘Home Run’ Temptation
Written by: MDCI Blogging TeamTuesday, July 6th, 2010 | FDA Medical Device Regulations, Medical Device Clinical Trials, Medical Device Market | No Comments
This article continues our series regarding the services that MDCI is most often called to provide new medical device start-ups as they navigate towards bringing a new product successfully to market.
Dreaming big is an important part of what it means to be an entrepreneur. In the medical device industry, however, it is important to be able to carefully manage hopes, dreams and visions so that they can help move your company towards its goal of bringing a device to market in the most effective way possible.
Shifting from a Treatment Model to Personalized Medicine - The Role of the Medical Device Industry
Written by: MDCI Blogging TeamThursday, July 1st, 2010 | Industry News and Innovations, Medical Device Market | No Comments
Personalized medicine is a term that has become something of a media buzzword over the past 12 months, due in part to the increased attention paid to the field by those on both sides of the current healthcare debate. While this phrase might be only now entering the common lexicon used by news outlets reporting on the health industry, MDCI has been actively involved in personalized medicine for many years, and we consider it one of our organization’s core competencies. › Continue reading
Pre-Market Clearance Changes - 510(k) Update
Written by: MDCI Blogging TeamMonday, June 28th, 2010 | FDA Medical Device Regulations, Industry News and Innovations | No Comments
At MDCI we have been keeping a close eye on the upcoming changes that could be made to the current 510(k) clearance process for licensing medical devices through the FDA. As we have stated in the past, although these types of changes may at first seem daunting to companies which have an established licensing process in place, brand new medical device manufacturers can take heart that at least some of the new practices and requirements being introduced by the FDA should make certain aspects of 510(k) clearance less of a headache. › Continue reading
FDA and NIH Roll Out Road Map for Personalized Medicine Medical Devices
Written by: MDCI Blogging TeamThursday, June 24th, 2010 | FDA Medical Device Regulations, Industry News and Innovations, Medical Device Quality Assurance | No Comments
Both the FDA and the NIH have recently taken public steps towards developing what they have referred to as a ‘road map’ outlining the future of personalized medicine. The decision to come forward and engage the industry in a frank discussion regarding in vitro and other forms of diagnostic and genetic testing is a positive indicator for medical device companies who have until now been forced to operate in an atmosphere of regulatory uncertainty. › Continue reading
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- FDA Publishes Rule to Require PMA or PDP for Four Class III Preamendment Devices
- Industry Slow to Respond to FDA Call for Infusion Pump Assurance Case Reports and Clinical Evaluations
- FDA Update - CDRH Issues Medical Device Recommendations
- Q1 Conference in Baltimore Highlights FDA Regulatory Challenges for Combination Products
- FDA Could Tighten Focus on Human Factors Testing for Medical Devices