What You Need to Know About the FDA’s New Guidances on the 510(k) Program

The FDA, in its efforts to continually improve and streamline the regulatory process, recently issued three important draft guidances regarding the widely utilized 510(k) pathway. These guidances aim to bring the pathway more efficient and effective in evaluating the safety and efficacy of medical devices.

Here are key actions for each guidance.

From “Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission” 

• Rely on These Sources of Data

  1. Current FDA-recognized voluntary consensus standards

  2. FDA guidance document

  3. Medical Device Development Tool (MDDT) 

  4. Widely available and accepted method published in the public domain 

  5. Scientific literature for the context of use, or found acceptable through the submitter’s own previous premarket submission

• Search the Following Databases to Understand Post-Market Risk 

  1. Manufacturer and User Facility Device Experience (MAUDE) Database

  2. Medical Device Reporting (MDR) Database

  3. MedSun Reports Database

• Avoid Use-Related or Design-Related Recalls

  Search the the Medical Device Recalls Database and de-prioritize potential predicate devices that have had Class I recalls where the root cause was related to use or design

From “Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions” 

• Consider these factors to trigger the need for clinical data:

  1. There are differences between the indications for use of the new device and the predicate (e.g. difference in patient population, disease, anatomical site, etc.) device, and clinical data may be needed to determine SE

  2. There are differences between technological characteristics of the new device and the predicate device, and clinical data may be needed to determine SE (e.g. differences in materials, design, energy source, etc.)

  3. SE between the new device and the predicate device cannot be determined by nonclinical testing (analytical, bench, and/or animal)

  4. A newly identified or increased risk for the predicate device suggests clinical data may be needed for the new device in order to determine SE (ex: increase in adverse events, class I recalls, etc.)

From “Evidentiary Expectations for 510(k) Implant Devices”

• Indications for Use

  Consider the Patient Population and unique clinical considerations for implants related to that population

• Consider These Specific Risks Associated with Implants

  1. Risks associated with everyday activities (e.g., the effect to the implant during airport security screening or exposure to magnetic fields)

  2. Risks associated with ongoing or future medical care (e.g., magnetic resonance or interaction with other implants)

  3. Risks associated with reoperation or revision associated with the implant

  4. Risks that may vary between different patient populations based on patient demographics

  5. Risks associated with duration of use (e.g., physical discomfort or other adverse events)

  6. Risks associated with user interaction with the implant, including considerations regarding user training and instructions for ongoing maintenance of the device and/or device updates (e.g., software or firmware updates)

  7. Risks associated with device design/ergonomics and human factors issues related to use by a physician

  8. Risks associated with the implantation procedure, including shorter or longer operating time, infection, tissue damage caused by implantation, associated operative imaging radiation exposure, etc.

• Consider the Most Common Biocompatibility Tests and Pyrogenicity

  1. Cytotoxicity 

  2. Sensitization 

  3. Irritation or intracutaneous reactivity 

  4. Acute systemic toxicity 

  5. Material-mediated pyrogenicity

Review detailed test and data collection expectations for Non-Clinical Testing, Human Factors, Patient Experience Information, and Labeling in the guidance.

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