Tag Archives: fda

How to Study and Market Your Device in Four Steps Based on the FDA’s Regulations

The FDA’s 4 Steps for Guiding Medical Device Design & Marketing

Medical device manufacturers can market their devices in the US once they meet all applicable FDA regulations. These regulations can be broken down into four main steps and can guide medical device design. These steps simplify how the FDA regulates medical devices as per the Federal Food, Drug, and Cosmetics Act.

Step 1: Device Classification as Per Applicable Regulatory Controls
Step 2: Determine and Prepare the Correct Premarket Submission Package
Step 3: Send Premarket Submission Package to FDA and Participate in the Review
Step 4: Comply with Applicable Regulatory Controls Post FDA Clearance or Approval

Step 1: Device Classification as Per Applicable Regulatory Controls

All FDA-regulated medical devices are assigned a classification based on the device’s risk profile. High-risk medical devices are labeled class III and include products like long-term implants and pacemakers. Class II devices have a moderate risk profile and include products like ultrasonic diagnostic equipment and some surgical equipment. Low-risk medical devices like tongue depressors and bandages are class I devices.

A device’s classification is a good indication of what regulatory controls are necessary to ensure a product’s safety and efficacy profile. Generally, devices of the same classification are subject to the same regulatory controls and premarket submission packages. Regulatory controls are requirements that a manufacturer and the device must meet to market the product. These requirements include labeling requirements, claims requirements, record keeping, and reporting requirements.

Step 2: Determine and Prepare the Correct Premarket Submission Package

A premarket submission package is information a manufacturer must submit to the FDA prior to introducing a device into the market. Generally, class I devices do not require any premarket submission packages, and manufacturers can begin marketing these devices once all of the applicable regulatory controls are established. If no premarket submission package is necessary, then manufacturers can skip ahead to step 4.

There are two main types of premarket submission packages for class II and class III devices: Premarket Notifications and Premarket Approval Applications. Manufacturers can determine their device’s premarket submission requirements using the FDA’s product classification database.

Premarket Notifications, also called 510(k)s, are generally used for class II devices. These applications rely on establishing equivalency to an existing medical device based on intended use, technological characteristics, and performance testing. The medical device used to establish equivalence is called a “predicate device.”

Premarket Approval Applications (PMA) are typically used for class III devices. A PMA is different from a 510(k) because no predicate device is used to establish the product’s safety and efficacy profile. Manufacturers who submit a PMA will typically need to submit more performance data and potentially clinical data so that the FDA can evaluate the product’s safety and efficacy.

Step 3: Send Premarket Submission Package to FDA and Participate in the Review

Once a manufacturer has established all applicable regulatory controls and prepared the appropriate premarket submission package, they are ready to begin the FDA review process. Before submitting a premarket submission package, manufacturers must pay their Medical Device User Fees for the submission package. Once the fees are paid, the FDA will issue a “Medical Device User Fees Act (MDUFA) Cover Sheet.” This Cover Sheet should be included in the submission package. An electronic copy of the submission package should be submitted to the FDA according to the eCopy requirements.

Once the FDA receives the submission, they will perform an administrative review within two weeks to determine if the submission is substantially completed and ready for review. 510(k)s and PMAs are reviewed according to different timelines, and the FDA will contact the manufacturer with questions or requests for additional information through an “interactive review” process.

Step 4: Comply with Applicable Regulatory Controls Post FDA Clearance or Approval

Upon receiving FDA clearance or approval, manufacturers have a few more regulatory controls to meet before marketing the device. Manufacturers must complete establishment and registration requirements, manufacture according to cGMP, and meet labeling requirements.

Manufacturers are responsible for maintaining their FDA registrations and completing all post-market activities throughout the device’s lifetime. Step 4 is an ongoing step that manufacturers must assess periodically to ensure their product meets all FDA requirements.

If you have an idea for a medical device, DeviceLab can help you take it to production with our full-service medical device design. Regardless of whether your medical device is a Class I, Class II, or Class III, our team has the experience and knowledge to engineer your product so that it meets all FDA requirements. Contact us today to schedule your personal free and confidential consultation.

How to Study and Market Your Device in Four Steps

Leave a reply

Medical device manufacturers can legally market their devices in the US once they meet all applicable FDA regulations. These regulations can be broken down into four main steps and can guide medical device design. These steps simplify how the FDA regulates medical devices as per the Federal Food, Drug, and Cosmetics Act.

Step 1: Device Classification as Per Applicable Regulatory Controls
Step 2: Determine and Prepare the Correct Premarket Submission Package
Step 3: Send Premarket Submission Package to FDA and Participate in the Review
Step 4: Comply with Applicable Regulatory Controls Post FDA Clearance or Approval

Step 1: Device Classification as Per Applicable Regulatory Controls

Step 2: Determine and Prepare the Correct Premarket Submission Package

A premarket submission package is information a manufacturer must submit to the FDA prior to introducing a device into the market. Generally, class I devices do not require any premarket submission packages, and manufacturers can begin marketing these devices once all the applicable regulatory controls are established. If no premarket submission package is necessary, then manufacturers can skip ahead to step 4.

Step 3: Send Premarket Submission Package to FDA and Participate in the Review

Step 4: Comply with Applicable Regulatory Controls Post FDA Clearance or Approval

”Breakthrough Devices” and the FDA SteP Program

Leave a reply

As part of the “21st Century Cures Act” in 2017, the FDA introduced a new program for innovative medical devices and combination products designed to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions. This program is called the “Breakthrough Device Program,” and it is a voluntary program to facilitate market access by creating a collaborative review process with the FDA with the goal of expedited review.

To be eligible for this program, the medical device or combination product must meet a set of criteria and “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.” However, healthcare innovation goes beyond the treatment or diagnosis of life-threatening or irreversibly debilitating conditions.

Manufacturers are consistently designing innovative products that improve the safety of current standards of care. These products are not eligible for the Breakthrough Device Program because the underlying conditions are not linked with morbidities and mortalities.

To complement the Breakthrough Device Program, the FDA introduced the “Safer Technologies Program (STeP),” with the final guidance document released in January 2021. Like the Breakthrough Device Program, STeP is an optional program for medical devices and combination products. It is designed to facilitate market access by creating a collaborative review process with the FDA to expedite review.

STeP is designed for products that are meant to diagnose or treat conditions that are not life-threatening or are considered reasonably reversible and provide an improved safety profile of existing treatments. Medical devices reviewed under STeP will still be required to submit a 510(k) or PMA as applicable.

STeP Benefits

Manufacturers who are early in their medical device design process may want to consider applying for STeP. The program is designed to bring eligible products to market sooner. This is done by earlier engagement with the FDA prior to submitting a 510(k) or PMA.

STeP is designed to allow manufacturers and the FDA to review data development plans and have more frequent touchpoints during product development. These touchpoints will ultimately lead to a PMA or 510(k) that includes all of the necessary data for the FDA to make a judgment on safety and efficacy.

Manufacturers who want to utilize STeP should consider engaging with the FDA early in the product’s development to fully utilize this program’s benefits. Once a STeP medical device is submitted via a 510(k) or PMA, manufacturers can expect a prioritized review process.

STeP Eligibility Criteria

Manufacturers who are seeking to participate in STeP must meet both eligibility factors as described below:

Manufacturers who are not eligible for STeP but have questions for the FDA about their medical device can still receive feedback via the FDA’s Q-Submission Process.

STeP is an excellent opportunity for manufacturers to engage with the FDA earlier in their product’s development, which will potentially allow for a smoother, faster review period.

DeviceLab and FDA Compliance for Your Medical Device Project

DeviceLab is a full-service device design and engineering company, helping you take your medical device idea all the way to production. We help ensure your products are compliant with all FDA regulations so you can get your product to market faster. Contact us today to schedule your confidential free consultation.

Medical Software Compliance & HIPAA’s Protection of Patient Data

Leave a reply

Software as a Medical Device (SaMD) is defined by the FDA as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” Within the medical device industry, SaMD and cybersecurity have been a topic of conversation as the FDA implements a regulatory framework for digital platforms. As manufacturers develop innovative methods to utilize software to collect patient data, they need to ensure their products protect patient data privacy and any potential data breaches. The Health Insurance Portability and Accountability Act (HIPAA) has provided the healthcare industry with a set of standards and framework to address data protection.

HIPAA was issued by the Department of Health and Human Services to protect patient health information in insurance, healthcare, and hospital settings by the creation of standards. These entities who collect, receive or store protected health information are required to comply with HIPAA standards and must perform audits to identify potential data violations or cybersecurity breaches.

The methods of collecting, receiving, and storing protected health information continues to evolve with advances in healthcare IT technology. Medical devices are an integral part of the infrastructure that collects, receives, and stores patient data.

Medical Device Manufacturers Must Ensure Medical Software Is HIPPA Compliant

Four Factors Software as a Medical Device Manufacturers Should Ask Themselves To Understand if They Need To Be Compliant With HIPAA

• What is the purpose of collecting this data?
• Is this data identifiable or using any protected health information (PHI)?
• Who will have access to any PHI? Only the data’s owner (i.e., patient), a medical professional, third-party associates, manufacturer?
• Which of these entities will get access to PHI from the software?

In the medical device world, manufacturers perform verification and validation testing to ensure their products meet the defined design inputs and defined user needs. HIPAA compliance and cybersecurity is no different and will need to be a part of the software design requirements. Manufacturers are obligated to perform verification and validation testing on software to ensure compliance with the requirements defined by HIPAA standards.

HIPAA regulations ensure that patient’s data is protected and that the entities that house this data have processes in place to protect patient data in the case of any data breaches or threats. Manufacturers share the responsibility to ensure data safety by performing verification and validation testing for their software against reasonably anticipated data risks.

Contact DeviceLab Today For HIPAA Compliant Medical Device Software Development Services

At DeviceLab, we provide a full-service device design and engineering company that takes your idea from concept to production. When we create a device, we design the software to help you achieve regulatory compliance and meet HIPAA standards. Our systems will ensure data collected by your medical device is secure and protected from unauthorized access and tampering, using encrypted transmission protocols and validation testing. To schedule a free and confidential consultation, contact us today.

FDA Medical Device Classification

Leave a reply

FDA has a public obligation to regulate and control the distribution of medical devices for public safety. To do this, medical device manufacturers provide information and data about their product to the FDA to assess the product for safety and effectiveness. However, not all products require the same level of review by the FDA. A low-risk product like a tongue depressor does not require the same level of regulatory oversight as a pacemaker.

There are three categories of medical device requirements or regulatory controls. The type of applicable regulatory controls is based on medical device classification. FDA medical device classifications are based on risk to the user. Class I medical devices are the lowest risk products (i.e., the tongue depressor), and Class III devices carry the most risk (i.e., the pacemaker).

Class I Medical Devices

FDA defines Class I medical devices as “not life-supporting or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and which does not present a potential unreasonable risk of illness or injury.” Examples of Class I medical devices include products like stethoscopes, bandages, and wheelchairs. These products are typically only subject to general controls.

General controls are requirements around adulterations, misbranding, registrations, banned devices, notifications, and other remedies, records, and reports. These are requirements a manufacturer must meet prior to marketing the medical device.

The FDA does not typically need to review safety or performance data regarding the safety and effectiveness of these products because these general controls are sufficient to provide a reasonable assurance of effectiveness and safety or because the device fits the definition of a Class I device.

Class II Medical Devices

Most medical devices are considered class II devices and present a moderate risk to the user, such as ultrasonic diagnostic equipment, x-rays, and needles. Class II medical devices are always subject to the same general controls as the class I devices.

Special Controls of Class II Medical Devices

Typically, class II medical devices are subject to special controls. Special controls are device-specific requirements and include compliance with performance standards, quality system regulations of 21 CFR Part 820, post market surveillance, patient registries, special labeling requirements, and premarket data requirements. Prior to marketing, data is submitted to the FDA through a premarket notification or a 510(k) submission. Upon review, the FDA notifies the manufacturer that the device is legally marketable.

Class III Medical Devices

Medical devices that cannot establish safety and effectiveness through general controls and special controls are class III devices. These devices are of the highest risk and include products such as balloon catheters, pacemakers, and heart valves.

Class III devices require a premarket approval application (PMA) from the FDA to thoroughly evaluate the medical device. PMAs typically requires clinical data and have a longer review process. Once the review is complete, the FDA will approve the medical device. Class III devices are typically life-sustaining, life-supporting, or long-term implantable devices.

Contact a Qualified Medical Device Design & Development Company Today

At DeviceLab, we are committed to delivering medical devices that achieve regulatory compliance. If you need a medical device designed, we can take your idea from concept to market and work with outside regulatory partners to handle clinical trials and submissions. Contact us today for your free and confidential consultation.