FDA Fashion Parade – Guidance Priorities for Fiscal 2020

25 October 2019 |

Red carpet

Each new fiscal year, FDA sets out its priorities for guidance development and publication over the coming year. It’s always a fascinating insight into the current regulatory fashions, and just like Hollywood, even comes with an A-list and B-list of celebrities.

So, what’s in fashion this coming season?

Final Guidance

Well, it’s a disparate list. The A-list includes plans to publish final guidance on review processes including

• CLIA waivers,
• combined 510(k) CLIA waiver submissions,
• the 510(k) Third Party Review program and the
• Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.

Also right up there on the red carpet is final guidance on the new Safer Technologies Program (STeP). That’s FDA’s program to expedite new technologies with significant clinical impacts which are not eligible for Innovative Device Program designation. There’s a separate accompanying document on Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation.

Device specific guidances are planned for labelling of surgical staplers and clinical decision support software and multiple function device products.

The A-list is rounded out with aspirations for guidance on Recognition and withdrawal of voluntary consensus standards and on Nonbinding feedback after certain food and drug administration.

On the B-List (some of which do manage to get published each year) are notable aspirations for guidance on point of care and self-monitoring blood glucose monitors and on the Unique Device Identification System (UDI) formats.

Draft Guidance

Earlier in the development pathway, FDA also lists its aspirations for draft guidance development in the coming year. These typically reflect current hot topics and emerging issues. It’s no surprise to see A-List priorities including:

• Labelling and Informed Decision Checklist for Breast Implants
• Cybersecurity requirements
• Distinguishing Servicing and Remanufacturing
• Manufacturing and QMS software validation
• Enforcement of UDI database submission for some Class I Devices

Finally, down at the bottom of the B-list drafts is an interesting one on Risk Categorization for Software as a Medical Device: FDA Interpretation, Policy and Considerations. Given the slow progress on the revision of IEC 62304, that one could turn out to be important.

FDA has a large library of guidance, some of which is very old, so each year the agency reviews a rolling selection of guidances from 10, 20, 30 and even 40 years ago. Some are historical oddities, (like the 1980s guidance on Open Door Operation of Microwave Ovens as a Result of Oven Miswiring). However, some remain very relevant. Of particular contemporary interest will be reviews of guidance on:

reprocessing of single use devices
• IDEs for spinal systems
Bayesian Statistics in Clinical Trials
Animal studies for cardiovascular devices
URLs in e-labelling

It remains to be seen which of these guidances are published in the coming year, but it pays to be ready to review and comment (go to http://www.regulations.gov) when the publications come out.

Link: Full list of proposed guidances (including review of historic guidances)

If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)


Recent Posts