The article reviews FDA guidance documents released in the past few months, including the new Final FDA guidance on biocompatibility, published June 16.
For anyone responsible for monitoring new and revised regulatory requirements, the FDA guidance documents are something you probably check at least once every month. If you are not familiar with these FDA resources, here are the links for two of the medical device FDA guidance documents webpages:
- Recent Medical Device Final FDA Guidance Documents
- Recent Medical Device Draft FDA Guidance Documents
New Final FDA Guidance Documents
The last time I reviewed an FDA guidance document was in February for the new guidance document from the FDA related to usability engineering and human factors engineering. There was a new final FDA guidance document released by the office of device evaluation on June 16: “Use of ISO 10993-1”.This biocompatibility guidance was expected for release in December, but the release was delayed.
Use of ISO 10993-1
The new biocompatibility guidance that was published last month provides specific guidance about the application of certain tests required for demonstrating biocompatibility. For example, test article preparation and risk assessments for the applicability of specific tests is addressed. A revised test matrix is included in the guidance document. Special considerations are provided for each of the following biocompatiblity tests:
- reproductive and developmental toxicity, and
- degradation assessments
New Final Rule for Symbology
In addition to FDA guidance documents, the FDA also released a final rule on symbology that will modify 21 CFR Parts 600, 801, and 809. The FDA is finally changing its position on the acceptance of harmonized symbols in place of English text. The FDA is accepting ISO 15223-1 as a recognized standard and allowing manufacturers to use the symbols instead of English text to facilitate global harmonization of labeling. The FDA is only allowing the use of Rx-Only as to indicate that a product is a prescription only. The guidance even defines the acceptable process for creating new product-specific pictograms. The effective date of the new final rule will be September 13, 2016.
New Draft FDA Guidance Documents
In addition to final FDA guidance documents, there have been several new draft guidance documents that were released recently:
- List of Highest Priority Devices for Human Factors Review
- Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”)
- Characterization of UHMWPE for Orthopedic Devices
- Technical Considerations for Devices for Additive Manufacturing
The second two FDA guidance documents focus on materials that are important for orthopedic manufacturers because UHMWPE is used as a wear surface for join implants, and many of the implants and instruments are now being manufactured using additive manufacturing instead of forging, casting or milling bar stock.
How to keep up on FDA Regulation Changes
If you are interested in keeping up on new and revised regulations from the FDA, I wrote a blog explaining four ways to identify new and updated FDA regulations. The blog identifies FDA webpages for the following four types of updates:
- Guidance Documents
- Recognized Consensus Standards
- Device Classifications
- Total Product Lifecycle (TPLC) Database
The ISO 15223-1 standard for medical device symbols has been released for several years, but the FDA did not recognize it until June 14, 2016. The recognition of the Standard is part of the implementation process for the new final rule regarding the use of symbology for medical device labeling. The timing of this new final rule coincides with the implementation of UDI labeling requirements for Class II devices. Also, the new European Medical Device Regulations now specify labeling requirements for the primary sterile packaging as part of the Essential Requirement (ER) 19.2:
- (a) an indication permitting the sterile packaging to be recognized as such,
- (b) a declaration that the device is in a sterile condition,
- (c) the method of sterilization,
- (d) the name and address of the manufacturer,
- (e) a description of the device,
- (f) if the device is intended for clinical investigations, the words: ‘exclusively for clinical investigations’,
- (g) if the device is custom-made, the words’ custom-made device’,
- (h) the month and year of manufacture,
- (i) an indication of the time limit for using or implanting the device safely,
- (j) an instruction to check the Instructions For Use for what to do if the sterile packaging is damaged etc.
These new requirements will require many manufacturers to redesign labeling for sterile packaging, and the ability to use symbology will assist in creating globally harmonized labeling.