FDA Guidance on Studying and Marketing Medical Devices – Part Two

In part one of our discussion of FDA premarket submission requirements for medical devices, we discussed the following FDA guideline steps.

• Step One: Classify Your Device and Understand Applicable Controls
• Step Two: Select and Prepare the Correct Premarket Submission

In this second part, we continue our discussion of step two. We also discuss the following steps:

• Step Three: Prepare the Appropriate Information for the Premarket Submission
• Step Four: Comply with Applicable Regulatory Controls, Including Establishment Registration and Device Listing

Step Two: Select and Prepare the Correct Premarket Submission

Information to Consider When Preparing a Premarket Submission

The FDA recommends that developers/sponsors of medical devices review the additional premarket submission requirements.

• Design Controls. “Class II and Class III devices must be designed in accordance with Design Controls under the Quality System Regulation (21 CFR 820.30). Most class I devices are not subject to Design Controls.” For additional information on Design Controls, applicants can review the FDA’s Design Control Guidance for Medical Device Manufacturers.
• Nonclinical Testing. The classification level of the medical device, the operating principles, the technology of the device, and the labeling of the device – all determine what information and testing are necessary to market a medical device. “Nonclinical testing performed in support of a premarket submission for a medical device should comply with the Good Laboratory Practices (GLPs) in 21 CFR 58.”
• Consensus Standards. “The FDA encourages the use of FDA-recognized consensus standards in premarket submissions. An integral part of a least-burdensome approach to device review is a reliance upon international consensus standards. Conformance is voluntary unless a standard is incorporated by reference into regulation (see the Standards Medical Devices Federal Register Documents). The guidance, The Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, explains how to use standards in device submissions and outlines the documentation needed to support their use, including declarations of conformity and test reports.”
  • FDA recommends that medical device manufacturers consider participation in the voluntary Accreditation Scheme for Conformity Assessment(ASCA) Program. The purpose of this program is “designed to decrease the burden of individual premarket submissions by enhancing consistency and predictability in the FDA’s approach to assessing conformance with ASCA-eligible standards in medical device premarket reviews.”
• Clinical Evidence. Clinical evidence is necessary for approval of PMAs, HDEs, some 510(k)s, and De Novo Classification Requests. Before starting a clinical study, the sponsor of the study may need the FDA to approve an Investigational Device Exemption (IDE). The clinical study must also be approved by the appropriate Institutional Review Board (IRB). Clinical studies must comply with all applicable IDE regulations and Good Clinical Practices (GCPs). The FDA resource for IDE and GCP regulations can be found at this link – Investigational Device Exemption (IDE).
  • Good clinical practices mean that FDA regulates the scientific studies that applicants for medical devices (and drugs, and biological products) submit. The doctors and clinical investigators who perform these studies must comply with specific statutes and regulations that are designed to “ensure the integrity of clinical data on which product approvals are based and to help protect the rights, safety, and welfare of human subjects.”
• Sponsors also need to review how to properly label their devices. The labeling should comply with the appropriate labeling regulations and should be included with the premarket submission. The FDA provides the following resource links for medical device labeling:
  • 21 CFR 801 Labeling
  • Device Labeling
  • Unique Device Identification System (UDI)
• Unique device identification (UDI) system. FDA also has a unique device identification (UDI) system to properly “identify medical devices through their distribution and use.” The UDI System will offer a range of benefits, including improved patient safety and post-market surveillance. Additional FDA resources regarding the UDI include the following:
• Unique Device Identification (UDI)
• Global UDI Database (GUDID)
• CDRH Learn (UDI Modules)

Step Three: Prepare the Appropriate Information for the Premarket Submission

After medical device developers prepare their premarket submission for their medical device, the premarket submission must be sent to the FDA. The developer/sponsor will need to work with the FDA staff during the FDA review process.

Developers/sponsors should review the following items before sending in their premarket submission:

• The FDA has the authority to charge fees for reviewing medical device market submissions. Our lawyers will help you understand what fees you need to pay. Businesses that qualify as a “small business” may be eligible for a reduction in many of these user fees.
• FDA allows for eCopies of medical device submissions.
• Applicants for premarket submissions can also use the voluntary eSTAR Program to help prepare the paperwork and PDFs for their medical device submission.

What happens after the FDA receives the market submission of your medical device?

After the FDA receives a medical device premarket submission, the agency will conduct the following types of reviews:

• Administrative review. Once the FDA receives a premarket submission, FDA will conduct an administrative review to determine if the submission documents are sufficient or whether more information is needed.
• Interactive review. During the review process, FDA staff will speak with applicants about their applications.
• An online portal. The FDA also has an online portal for sending and tracking the status of an applicant’s medical device premarket submission.

Step Four: Comply with Applicable Regulatory Controls, Including Establishment Registration and Device Listing

As we discussed earlier, the FDA has regulatory controls that apply to the different classes of medical devices. All medical devices are subject to general controls unless there is an appropriate exemption.

General controls require that a “device facility”:

(1) Register their establishments and list the medical devices the facilities market with FDA

(2) Manufacture their devices in accordance with current Good Manufacturing Practices

(3) Label their devices in accordance with labeling regulations

(4) Cannot adulterate or misbrand their medical device.

If the FDA exempts a medical device from premarket submission requirements, the FDA should state the exemption in the classification regulation for that device. If there is no exemption, the device facility/applicant must wait until the FDA provides “clearance” or approval before registering and listing. Registering the device does not indicate that FDA has approved the device.

Some devices (many Class II devices) also have special controls to ensure the safety and effectiveness of the medical device. Special controls are usually device-specific and include:

• Performance standards
• Postmarket surveillance (which may include warning letters)
• Patient registries
• Special labeling requirements
• Premarket data requirements
• Guidelines

Class III devices generally require approval of a Premarket Approval Application (PMA).

Applicants for FDA approval of medical devices must understand the type of approvals medical device developers need and what supporting evidence the developers must provide. Our skilled healthcare lawyers help applicants understand what information applicants must supply with their premarket submission, how to prepare the submission, and how to comply with FDA regulatory control requirements.

Medical device companies should contact Cohen Healthcare Law Group, PC to discuss their FDA compliance requirements. Our experienced healthcare attorneys advise medical companies and practices about healthcare compliance laws and regulations.