FDA Issues Fresh Draft Guidance On 510(k) Benefit-Risk Review

By Nick Otto

Manufacturers submitting 510(k)s may now need to show FDA reviewers that the risks and benefits of a candidate device are acceptable and substantially equivalent to those of the predicate device.

According to draft guidance issued recently, industry should be able to demonstrate the likelihood that a risk or beneficial effect will occur. For example, a modified device may cause a benefit in only a few patients, or broadly across the patient population, and a specific risk may be rare or common. Those situations would raise different considerations in reviewing a 510(k) submission, the agency adds.

According to the guidance, device makers will need to identify the specific benefits a device is intended to provide and the specific endpoints that demonstrate them.

The assessment of benefits should include:

• Type of benefit(s)
• Magnitude of the benefit(s)
• Probability of the patient experiencing one or more benefit(s)
• Duration of effect(s)

On the flip side of the coin, the assessment of risks should take into account:

• Severity, types, number, and rates of harmful events associated with the use of the device, including:
  1. Device-related serious adverse events
  2. Device-related non-serious adverse events
  3. Procedure-related complications
• Probability of a harmful event
• Probability of the patient experiencing one or more harmful event(s)
• Duration of harmful events
• Risk from false-positive or false-negative results for diagnostics

One factor The National Law Review points to as “noteworthy” includes the additional factor for patient tolerance, noting this clause was also discussed in an earlier premarket approval (PMA)/De Novo guidance the agency issued.

The guidance also notes that some patients are willing to accept a higher level of risk to achieve a higher probable benefit. The agency may consider evidence relating to patients’ perspective on what constitutes a meaningful benefit, as some patients may find more value in a benefit than others.

Comments on the draft are due by Oct. 14.