There is always uncertainty baked into any government submission process, and it’s helpful to companies if there is a way to tackle issues before submitting a 510(k).
The FDA Pre-Submission is a way for companies to request feedback from the agency on potential and planned medical device, biologics, and drug submissions. It’s a great service to take advantage of, only we’ve found that it tends to get underutilized.
The Pre-Submission allows you to request formal feedback on your medical device before you make a move to submit your 510(k). This is known as a Q-Submission, which under the guidance published by FDA, allows you to request the following:
The Pre-Submission process was born out of a need to provide expanded access to the FDA and allow companies to get valuable feedback ahead of time. This can help keep your company on track for getting your device to market as soon as possible — it helps to be aware of possible issues ahead of time and deal with them before final submission.
The guidance for Pre-Submission is clearly laid out in the FDA document Requests for Feedback on Medical Device Submissions. If you happen to have a combination product (such as a stent that administers a drug or an inhaler), there may be other, similar processes you need to go through. The document to check out, in that case, is Guidance for Industry.
In any case, the basic definition of what a Pre-Submission is remains the same. It is a formal written request from an applicant/sponsor for feedback from the FDA to be provided in a formal written response, meeting, or teleconference. The feedback is documented in meeting minutes.
It’s a great way to meet with the FDA, ask them some questions, then document that information for future use. It boils down to identifying key issues that keep you up at night and making your overall submission process easier.
The FDA continues to expand its Pre-Submission program to include several different medical device submissions that a manufacturer may choose to bring a device to market. The comprehensive list of submission types is known collectively as Q-Submissions(Q-Subs), which include:
E, De Novo request, 510(k), Dual, BLA, IND), Accessory Classification Request, or CW.
Should I really use a Pre-Submission? This is a key question that companies often ask, so it’s important to understand the relative pros and cons. Here are some of the pros:
One thing to note is that you’re not getting a final acceptance at this stage; the FDA will never give you this until the actual submission. However, it’s well worth getting the early heads-up.
There’s always a money and time aspect. You’re looking at $5,000 to $25,000 to have a consultant help you with a Pre-Submission. If all timelines are met, the typical process takes 60–75 days.
A con that is frequently raised is, “What if they tell us no and say we have to do X, Y, and Z instead of what we’re already doing?”
Our answer to this will always be the same: Isn’t it better to know about this now rather than go ahead with your 510(k) submission and find out then? The FDA will pick out that same issue regardless, so it’s a much better use of your time to find out about it during a Pre-Submission.
Perhaps these cons are a big part of the reason that the Pre-Submission is underutilized, but I would strongly suggest that you don’t let them put you off using it. The FDA actively encourages medical device manufacturers to use the Pre-Submission because doing so helps the final submission's overall quality.
A Pre-Submission program is a valuable tool that tends to be underutilized. Perhaps companies are put off by the idea that the process will take too much time and money, or they’re worried that the FDA will tell them they need to do something they hadn’t already planned on doing. In Kaiyan Medical, we make sure our devices are FDA cleared and we constantly communicate with the FDA. Like many other medical device companies, you may find it’s well worth the time and money.
Today's customers expect nothing less than products of the highest quality, and it is incumbent on all manufacturers to assure this expectation is met. A proven technique for checking whether a manufacturing process is in control is a manufacturing audit.
A manufacturing audit is a comprehensive inspection of a process to determine whether it is performing satisfactorily. A manufacturing audit is usually limited to a small portion of units produced, but the manufacturing processes involved are reviewed thoroughly. An audit does not replace normal quality control efforts, but supplements them.
Medical audit is a systematic approach to peer review of medical care in order to identify opportunities for improvement and provide a mechanism for realizing them. Medical audit and clinical audit are often used interchangeably, but clinical audit might be considered to cover all aspects of clinical care-for example, nursing and the role of paramedical staff-whereas medical audit relates to practices initiated directly by doctors. It complements and may partly overlap financial audit, utilization review, and management of resources, but is primarily clinical, not managerial; its focus is the process and results of medical care rather than the use of resources and it is the responsibility of doctors rather than managers.
There are many reasons for conducting a manufacturing audit:
Kaiyan Medical got another audit supplier recognition by Made-in-China. We like to keep our audits and quality standards to the top in order to assure the best experience for our customers and clients
https://www.bmj.com/content/bmj/299/6697/498.full.pdf
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a workgroup to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).
What is MDSAP?
The Medical Device Single Audit Program (MDSAP) is a program that conducts a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.
Why was the MDSAP developed?
The MDSAP was developed to enable appropriate regulatory oversight of medical device manufacturers’ quality management systems. The idea is to promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority. Also, in the longer term, promote greater alignment of regulatory approaches and technical requirements based on international standards and best practices
Which Regulatory Authorities are part of the MDSAP?
The MDSAP was developed by representatives of the Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA, and the U.S. Food and Drug Administration (FDA). All regulatory authorities participating in the MDSAP are equal partners in the program.
Which manufacturers are eligible for an MDSAP audit?
Any manufacturer of medical devices is eligible. However, each regulatory authority may establish exclusion criteria for some manufacturers. It is important to note that manufacturers that participate in the MDSAP program are responsible for securing and maintaining a contract with an MDSAP recognized auditing organization. In other words, medical device manufacturers are responsible for paying for MDSAP audits conducted by an auditing organization.
Does the MDSAP add requirements for the manufacturer?
No. The MDSAP audit model was developed to cover existing requirements from the Regulatory Authorities participating in the MDSAP. The program does not add any new requirements to existing requirements from ISO 13485.
What are the potential benefits?
What are the costs associated with MDSAP audits
The cost of conducting an MDSAP audit is dictated by the commercial arrangement between the medical device manufacturer and the authorized MDSAP auditing organization.
COVID-19 Remote Audits
The spread of Covid-19 globally has resulted in the imposition of quarantine orders and travel restrictions that are affecting the ability of auditing organizations to perform MDSAP audits.
On-site audits can only be substituted with remote audits where travel restrictions or social/physical distancing as a result of the pandemic prevent on-site audits from occurring.
In Kaiyan medical, we believe in the benefits of light. We believe in healing without chemicals. With our lights, we want you to have the best version of yourself. More at kaiyanmedical.com
For more detailed information about MDSAP please take a look at their documentation.
Useful links:
Section 201(h) of the Food, Drugs, and Cosmetics Act defines a medical device as any healthcare product that does not achieve its principal intended purposes by chemical action or metabolized.
The FDA approval of an IDE is required for US human study of a significant risk device that is not approved for the study's indication.
Device trials are unique.
Background of medical issue, the study goals, and why this study will further the science.
Should include:
Discussion of the appropriateness of endpoint parameters, hypotheses, and success criteria
Should evaluate the safety and effectiveness of the device in the population expected to be indicated.
Driven by either:
The minimum number of patients and/or minimum duration of follow-up may be required depending on:
Generally used to evaluate additional meaningful claims.
One size does not fit all for device trials. Pivotal studies should be designed to evaluate whether there is a “reasonable assurance of safety and effectiveness.” PMA approbation is based upon a Benefit-Risk assessment that strongly considers the outcome of primary safety and effectiveness endpoints. Secondary endpoints are generally used to support claims if the primary endpoints are successful. All endpoint analyses and definitions should be clearly pre-specified in the approved clinical protocol.
Different types of clinical research are used depending on what the researchers are studying. Below are descriptions of some different kinds of clinical research.
Treatment Research generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy.
Prevention Research looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.
Diagnostic Research refers to the practice of looking for better ways to identify a particular disorder or condition.
Screening Research aims to find the best ways to detect certain disorders or health conditions.
Quality of Life Research explores ways to improve comfort and the quality of life for individuals with a chronic illness.
Genetic studies aim to improve disorders' prediction by identifying and understanding how genes and illnesses may be related. Research in this area may explore how a person’s genes make him or her more or less likely to develop a disorder. This may lead to the development of tailor-made treatments based on a patient’s genetic make-up.
Epidemiological Studies seek to identify the patterns, causes, and control of disorders in groups of people.
An important note: some clinical research is “outpatient,” meaning that participants do not stay overnight at the hospital. Some are “impatient,” meaning that participants will need to stay for at least one night in the hospital or research center. Be sure to ask the researchers what their study requires.
Phases of Clinical Trials: When Clinical Research is Used to Evaluate Medications and Devices
Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as psychotherapy or medications. Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions.
Examples of Other Kinds of Clinical Research
Many people believe that all clinical research involves testing new medications or devices. This is not true, however. Some studies do not involve testing medications, and a person’s regular medications may not need to be changed. Healthy volunteers are also needed so that researchers can compare their results to the results of people with the illness being studied. Some examples of other kinds of research include the following:
