A potential silver lining for medical device developers and manufacturers exists in the FDAs response to 2016 “21st Century Cures Act”, with publication of a draft Guidance document outlining the agencies planned changes to the medical device approvals process and their oversight activities.
The 22 page document makes for heavy reading, so we’ve highlighted some of the key points that you should be aware of as you manufacture or develop medical devices for the US market. Many of the changes will have a positive impact upon your preparations for marketing authorisation submissions; 510(k), PMA, De Novo, IDE, etc.
1. 510(k) exemptions
FDA periodically reviews premarket and post-market activities to identify Class I and Class II devices that no longer require a 510(k) submission. The list of exemptions is regularly updated, so it is worth checking before setting your regulatory strategy for a new medical device.
2. Enforcement discretion
Additionally, enforcement discretion is being exercised for certain products, to focus oversight on medical devices that could pose a higher risk to patients. Information can be found for specific product codes by searching the FDA product classification database for submission type: “Enforcement Discretion”.
3. Changes to part 820
As we recently reported, FDA plans to replace parts of 21 CFR 820 (Quality System Regulation) with requirements of ISO 13485:2016, harmonising with other key regulators around the globe. This will remove a significant barrier to entry for manufacturers, particularly the smaller organsiations.
4. Aligning expectations with other regulatory authorities
FDA expects to be in a position to leverage data and regulatory decisions from other regulatory authorities, by aligning requirements other regulators’ requirements. The focus will be on reviewing scientific data, rather than the methods used to generate it. The agency plan includes recognition of additional international standards, to facilitate the move.
5. A “bottom-up” approach to request for information
FDA will request from manufacturers the minimum information needed to address questions or issues. The agency will consider a “bottom-up” approach to data requests, so in some cases descriptive information (such as dimensional analysis or materials comparisons) may be all that is needed. If that proves insufficient, it may be that some non-clinical performance testing data is required. Animal or biocompatibility data or ultimately data from clinical investigation may be requested if none of the earlier data sources provide adequate data to address the question or issue at hand.
6. Manufacturer submissions
Manufacturers will be expected to submit materials that are “least burdensome” to review/assess. Your documentation needs to be concise, well organised and clear. Including rationales for responses to agency questions will go a long way towards expediting review and promote open communication with the FDA.
7. Use of post-market surveillance data
Consider where post-market surveillance data can be utilised, instead of gathering new data from pre-market investigations.
8. Alternatives to Clinical Investigation
Alternative sources of clinical data, such as;
- Peer reviewed literature,
- Data generated outside of the US,
- Real-world evidence and,
- Well documented case histories,
may be used, where it is appropriate to help assessment of device safety and effectiveness.
9. “families” of medical devices
Bundling of submission documents to cover multiple devices, or indications, within a single submission, may be an appropriate route for agency review, where scientific and regulatory issues for the devices / indications can reasonably be dealt with in the same review.
As you’ve read this far, it’s fairly safe to assume that the topic of regulations and quality management interests you. You can search and read other articles in this topic here: http://threecircles.eu/category/quality/