Since 2018, the FDA has been in talks with public stakeholders on modernizing the 510(k) premarket submission programs. Introducing the Safety and Performance Based 510(k) pathway was one such effort to bring the 510(k) programs up to speed with the rapid advances in technology and changes in safety and performance criteria.

In late 2020, the FDA has introduced FIVE (5) medical devices which can be submitted for evaluation through this special pathway and their performance criteria in the form of guidance documents. They are Spinal Plating Systems, Orthopedic Non-Spinal Metallic Bone Screws and Washers, Magnetic Resonance Receive-Only Coils, Cutaneous Electrodes for Recording Purposes and Conventional Foley Catheters. The guidance documents can be consulted here.

It is to be noted the Spinal Plating Systems ‘s performance criteria guidance document does not cover the plating systems that are attached to the posterior spine or the occiput. As for Orthopedic Non-Spinal Metallic Bone Screws and Washers, the criteria exclude bone screws or washers that are intended for mandibular, maxillofacial, cranial, and orbital fracture fixation or for use in the spine.

The Safety and Performance Based Pathway is appropriate when the FDA has determined two important criteria. Firstly, the new device needs to have the same indications for use as, and technological characteristics that do not raise different questions of safety and effectiveness than the identified predicate; Secondly, the new device has to meet all the FDA-identified performance criteria, listed in the official guidance documents issued from time to time.

In addition to the above five devices introduced in the first batch, the FDA will continue to issue draft and final guidance(s) to apply this Safety and Performance Based Pathway to additional types of devices with corresponding FDA-identified performance criteria. It aims that this alternative 510(k) pathway can ensure safety conditions as well as, decrease the time and cost in the review.

Details on how to prepare and submit a 510(k) using the Safety and Performance Based Pathway and other necessary information can be directly consulted in the following official page of the US FDA.

 

References:
1. Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff -DECEMBER 2020

  1. 2. Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff- DECEMBER 2020
  2. 3. Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff - DECEMBER 2020
  3. 4. Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff - AUGUST 2020
  4. 5. Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff-AUGUST 2020
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