FDA Watch: Agency Finalizes New Medical Device Marketing Pathway & Okays Direct Lab Reporting of PGx Test Results

On Jan. 22, the FDA issued final guidance establishing a new alternative pathway for getting medical devices to market. Under the “Safety and Performance Based Pathway” (new Pathway), new product approval will be based on consensus standards rather than direct predicate comparisons with previously approved devices.

How the New Pathway Works
The new Pathway is to be used when FDA determines that:

• The new device has indications for use and current technological characteristics that don’t raise safety and effectiveness questions different from identified predicates;
• The predicate is within the scope of the list of eligible device types;
• The performance criteria align with the performance of one or more modern legally marketed devices of the same type as the new device; and
• The new device meets all FDA-identified performance criteria.

If the above criteria are met, the FDA may request and review underlying data and testing methodologies as necessary to find that a new device is substantially equivalent. If any of the criteria aren’t met, the manufacturer can seek approval through the Traditional, Special or Abbreviated 510(k) pathways.

When the New Pathway Will Become Available
In its press release, the FDA outlined its implementation plans:

• Create a list of device types eligible for the new Pathway with input from industry;
• Establish criteria applicable to each device type;
• Issue new guidance listing the eligible device types and corresponding criteria;
• Hold a webinar and take other steps to educate stakeholders how to use the new Pathway.

Once the new Pathway launches, the FDA will publish the list of device types and applicable criteria on its website and review them on a periodic basis.

Discouraging Use of Older Predicates
In a separate action, the FDA issued a notice requesting comments on approaches to drive sponsors to offer patients devices with the latest improvements and advances. Specifically:

• Should the FDA publish a list of devices or manufacturers that rely on predicates that have been on the market for more than a certain number of years?  If so, what number of years should that be?
• Should the FDA consider using other criteria to inform its point of reference?
• What other actions should the agency FDA take to promote use of more modern predicates?
• Should the FDA consider certain actions that might require new authority, such as making at least some older devices ineligible as predicates?

Deadline to comment: April 22.

New FDA Approvals
The other headliner from January was the agency’s first ever approval for a direct-to-consumer test company (23andMe) to provide pharmacogenetic test results to customers without a doctor’s order. 23andMe CEO and co-founder praised the decision for opening “the door for consumers to work with their health providers to better manage their medications,” However, some experts caution that patients may be tempted to bypass their doctors and medical lab testing if they’re directly informed how they metabolize medications on the basis of genetic testing.

Here’s a look at the other key FDA approvals announced at the end of December through the final days of January:

New CE Marks & Global Certifications
Notable European CE certifications:

Other international clearances announced during the period: