medical device consulting

Although FDA medical device regulations are centrally located in one place, the FDA homepage, this blog discusses four information areas you can monitor to create your own FDA medical device regulatory updates.

1. Guidance documents released (FDA-guidance),
2. Recognized standards (Recognized-Consensus-Standards),
3. Device classifications (Product Classification), and
4. Total Product Lifecycle (TPLC) database (FDA-TPLC).

Guidance Documents

When you check the FDA website for the new draft and final guidance documents, the webpage to monitor is http://bit.ly/newFDAguidance. This page had already had four new guidance documents in 2014, and in October 2013,  the FDA released an important update about the eCopy program for 510(k) submissions: FDA-eCopy.

Recognized Standards

The FDA has a separate database for all recognized consensus standards: Recognized-Consensus-Standards. This database is used to verify which Standards can be used for verification and validation testing of new devices, and the reference of any of these Standards in a device submission must also be accompanied by the completion of Form FDA 3654: http://bit.ly/Form-FDA-3654.

Device Classifications

Changes to device classifications and/or regulatory approval pathways are rare at the FDA, but you should periodically check the classification database to verify that there have been no changes. The most likely changes will be the addition or removal of recognized standards applicable to your devices. The database for looking up device classifications can be found at Product Classification.

TPLC Database

For each 3-letter product classification code, there is a database that shows all the recent 510(k) submissions and recalls and summarizes all the medical device reports submitted for severe injuries and deaths. This database, FDA-TPLC, should be monitored to proactively identify problems that occurred with similar products before they happened to your product. Also, there may be voluntary reports from user facilities regarding your device that were not reported directly to your company. The possibility of voluntary reports makes this a vital database to monitor weekly. Other resources include:

1. CDRH-news-updates – This is the page of the device division of the FDA (CDRH), where news and updates are posted. You may find it helpful to register for receiving the RSS feeds from this page so that you are informed of any updates as FDA posts them.
2. CDRH-Learn – This is the page where CDRH lists all the online training courses for medical device manufacturers. This includes popular courses such as the “Pre-market Notification Process – 510(k)s” and “Medical Device Recalls.” This page also had four recent updates: 1) “Investigation Device Exemption Process – IDE,” updated on December 6, 2013; 2) “Device Establishment Registration and Listing,” updated on July 31, 2013; 3) “Global Initiatives,” updated on October 31, 2013; and 4) “Unique Device Identification (UDI) System,” updated on December 23, 2013.

Next Steps

Review each of the above streams of information from the US FDA on a scheduled basis as preparation for quarterly management reviews and determine any potential impact on your organization’s quality system and procedures. This gap analysis should be performed by someone familiar with the specific process(es) addressed by the regulations. The most likely actions to be taken are:

1. Initiate specific changes to existing procedures.
2. Create new procedures or
3. Initiate a quality plan for more substantial changes to your quality system.

Management Review-Free Webinar Recording

If you need more help preparing for your management review, here’s a link to a free webinar I recorded: http://bit.ly/Clause5-6. You will also receive a management review slide deck, as well.