U.S. FDA & International Medical Device Consulting and Training Services
Please either fill out a Consulting Inquiry Form , phone 1-949-398-5222 or send an e-mail to firstname.lastname@example.org to quickly send us an inquiry regarding your consulting needs so we may discuss your issue confidentially, and provide you with an estimate or proposal of how can can assist you. All discussions will be held in confidence. We will sign a confidentiality or non-disclosure agreement upon request.
A recall is a very sensitive subject that can have a great impact on your customers, patients, and your company. Recalls need to be handled skillfully and appropriately to reduce the risk of possible injury to patients and users; as well as, to minimize the impact to your company, employees, and investors. Noblitt & Rueland can provide experts to assist you during this difficult time by assisting manufacturers in handling potential recall decisions, recall strategies, and recall activities.
A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. Since the first Medical Device Regulations in 1976, FDA Regulatory Policy under 21CFR7.40 and the precedents established by the Center for Devices and Radiological Health have made it clear that the “correction” in place or, the “removal” of a medical device by the manufacture, is a recall only when the device is in violation of FDA regulations. Almost always recalls are voluntary actions. A manufacturer will on its own voluntarily remove or correct a marketed product that the FDA considers to be in violation of the FD&C Act and against which FDA would consider initiating legal action, e.g., seizure. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request a recall. But in every case, FDA's role is to oversee a company's strategy and assess the adequacy of the recall.
Examples of the types of actions that may be considered recalls:
A recall is either a correction or a removal depending on where the action takes place.
Companies are sometimes confused by what a medical device recall entails. It does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often inform doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.
Medical Devices are developed and used in an environment of constant change. These changes are part of continuous ongoing efforts by the manufacturer to design and develop a device that meets the need for the user/and or patient or to enhance the effectiveness of the product. In some cases these enhancements are considered “Silent Recalls”, and pose a risk to health.
When an FDA-regulated product is either defective or potentially harmful, recalling that product removing it from the market or correcting the problem— and a clearly written notification to the user, is the most effective means for protecting the public.
Noblitt & Rueland can assist your firm in a potential or active recall situation with expert knowledge including:
Please either fill out a Consulting Inquiry Form , phone 1-949-398-5222 or send an e-mail to email@example.com with information on your situation so that we may discuss your issue confidentially and provide you with an estimate or proposal of how can can assist you. All discussions will be held in confidence. We will sign a confidentiality or non-disclosure agreement upon request.
Background & Experience: Noblitt & Rueland (N&R) is a 25+ year old consulting firm that specializes in the medical device technical-regulatory market. All of our consultants have a wealth of medical device experience, most with over 20 years of experience individually. Each of our consultants has their own specialty expertise such as FDA & ISO compliance in regulatory and quality systems, submissions (e.g. 510(k) & CE Marking), auditing, enforcement issues, complaints/MDRs/Recalls, software development, software verification & validation, software quality assurance, risk/hazard management, design control, biocompatibility, electrical safety, electrical interference, etc. As opposed to the services of a sole consultant working alone; the N&R management team, having considerable experience in the industry, helps the client identify the correct N&R consulting resource for a particular project. N&R management will then work with the primary or lead consultant (if a team is needed at the onset) in providing a sounding board for ideas, strategies, and thoughts regarding and throughout a project. As the project progresses, if additional specialty expertise would benefit the client during the project, the consultant or N&R managment will discuss the option with the client and only upon client approval will engage the appropriate N&R specialty consultant. Our team approach can greatly benefit clients because projects can be completed accurately and efficiently without the risk of venturing outside an individual consultant's expertise. Logistically this is also very beneficial since the project can be usually be completed under one Purchase Order and non-disclosure agreement
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