It seems like from an article I read the 510 K process is towards the CDRH center. CDRH employees have expressed concerns to the current 510 (K) program because some of the devices being evaluated are rather complex. The reviewers ability to make a well-informed decision was undermined by the poor quality of the 510 K submissions. There are three changes that the CDRH committee at the time wanted to be done:
1) A streamline pathway for lower-risk denovo devices
2) A new subclass (Class IIb) for moderate-risk devices
3) The creation of an internal CDRH Science Council
With these proposed changes to CDRH they also had changes towards the 510 K process it wanted as well.
• Streamlining the review process for innovative, lower-risk products, called the “de novo” process;
• Publishing guidance for industry to clarify when clinical data should be submitted to increase predictability and transparency;
• Developing a network of external experts who can use their knowledge and experience to help the agency address important scientific issues regarding new medical device technologies;
• Establishing a new Center Science Council of senior FDA experts within the agency’s medical device center to assure more timely and consistent science based decision making; and
• Improving training for CDRH staff and industry